Trial Outcomes & Findings for An Open Label Extension Study in Participants With Rheumatoid Arthritis (NCT NCT00837811)
NCT ID: NCT00837811
Last Updated: 2018-04-25
Results Overview
A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module. Participants were on treatment up to 48 weeks. If a participant completed 48 weeks of treatment, the post-study treatment follow-up started at the next visit, 4 weeks later (Week 52). If a participant discontinued treatment early \[early discontinuation (ED)\], the post-study treatment follow-up started immediately afterwards. Baseline was defined as Week 0 in this study \[which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)\].
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
182 participants
Primary outcome timeframe
Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52)
Results posted on
2018-04-25
Participant Flow
After ≥3 months treatment, investigator could choose 1-time dose increase \[120 milligrams (mg) LY2127399 (LY)\] for participants (pts) with ≥4 tender and ≥4 swollen joints. Additionally, 1-time dose decrease back to 60 mg LY permitted. Pts completing Week 72 completed study, but could be followed beyond Week 72 for B cell recovery (up to Week 112).
Participant milestones
| Measure |
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
|---|---|---|---|
|
Overall Study
STARTED
|
60
|
121
|
1
|
|
Overall Study
Received Any Amount of Study Drug
|
60
|
121
|
1
|
|
Overall Study
Had at Least 1 Efficacy Assessment
|
59
|
121
|
1
|
|
Overall Study
Included in Efficacy Analyses
|
59
|
120
|
1
|
|
Overall Study
COMPLETED
|
53
|
87
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
34
|
1
|
Reasons for withdrawal
| Measure |
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
6
|
0
|
|
Overall Study
Death
|
1
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
11
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
9
|
0
|
|
Overall Study
Sponsor Decision
|
0
|
2
|
0
|
Baseline Characteristics
An Open Label Extension Study in Participants With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
60 mg LY2127399
n=59 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
n=121 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
n=1 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 11.86 • n=5 Participants
|
51.5 years
STANDARD_DEVIATION 12.20 • n=7 Participants
|
61.5 years
STANDARD_DEVIATION NA • n=5 Participants
|
52.2 years
STANDARD_DEVIATION 12.08 • n=4 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
34 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
West Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Austria
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Brazil
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
Chile
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Hungary
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Region of Enrollment
India
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
12 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Region of Enrollment
Puerto Rico
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Romania
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52)Population: Participants who received any amount of study drug.
A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module. Participants were on treatment up to 48 weeks. If a participant completed 48 weeks of treatment, the post-study treatment follow-up started at the next visit, 4 weeks later (Week 52). If a participant discontinued treatment early \[early discontinuation (ED)\], the post-study treatment follow-up started immediately afterwards. Baseline was defined as Week 0 in this study \[which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)\].
Outcome measures
| Measure |
60 mg LY2127399
n=60 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
n=121 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
n=1 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Any TEAE
|
38 Participants
|
95 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Any SAE
|
4 Participants
|
16 Participants
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline through Week 112Population: Participants who received any amount of study drug.
For each planned laboratory evaluation, the range of values to be reported as AEs, regardless of causality, was pre-specified. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. Baseline was defined as Week 0 in this study \[which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)\].
Outcome measures
| Measure |
60 mg LY2127399
n=60 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
n=121 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
n=1 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
n=60 Participants
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
n=121 Participants
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
n=1 Participants
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
B-Lymphocyte Count Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
Blood Alkaline Phosphatase Increased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
Blood Cholesterol Increased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
Alanine Aminotransferase (ALT) Increased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
Aspartate Aminotransferase (AST) Increased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
Blood Immunoglobulin M (IgM) Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
Gamma-Glutamyltransferase (GGT) Increased
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
Hepatic Enzyme Increased
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
Neutrophil Count Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
Vitamin D Decreased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
White Blood Cell Count Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
Dyslipidaemia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
Hypercholesterolaemia
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
Hyperglycaemia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
Hyperlipidaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
Hypokalaemia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
Vitamin B12 Deficiency
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
Vitamin D Deficiency
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, up to and through Week 52Population: Participants who received any amount of study drug and had at least 1 post-baseline tender joint assessment; excludes site with GCP issues; Last observation carried forward (LOCF).
The number of tender and painful joints was determined by examination of 28 joints (14 on each side) which included: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. Joints were assessed by pressure and joint manipulation on physical examination. The participant was asked for pain sensations on these manipulations and the investigator watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in tender joint count indicated an improvement in the participant's condition.
Outcome measures
| Measure |
60 mg LY2127399
n=59 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
n=120 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
n=1 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Tender Joint Count [Individual Component of the American College of Rheumatology (ACR) Core Set]
|
-9.2 tender joints
Standard Deviation 8.0
|
-6.5 tender joints
Standard Deviation 8.2
|
-12.0 tender joints
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to and through Week 52Population: Participants who received any amount of study drug and had at least 1 post-baseline swollen joint assessment; excludes site with GCP issues; LOCF.
The number of swollen joints was determined by examination of 28 joints (14 on each side) which included: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in swollen joint count indicated an improvement in the participant's condition.
Outcome measures
| Measure |
60 mg LY2127399
n=59 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
n=120 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
n=1 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Swollen Joint Count (Individual Component of the ACR Core Set)
|
-7.6 swollen joints
Standard Deviation 6.8
|
-5.3 swollen joints
Standard Deviation 6.6
|
2.0 swollen joints
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to and through Week 52Population: Participants who received any amount of study drug and had at least 1 post-baseline self-rated assessment of disease activity; excludes site with GCP issues; LOCF.
Participant's assessment of their current arthritis disease activity using a visual analog scale (VAS), which ranged from 0 millimeters (mm) (no arthritis activity) to 100 mm (extremely active arthritis). Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in disease activity score indicated an improvement in the participant's condition.
Outcome measures
| Measure |
60 mg LY2127399
n=57 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
n=117 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
n=1 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Participant's Assessment of Disease Activity (Individual Component of the ACR Core Set)
|
-26.1 mm
Standard Deviation 27.1
|
-16.7 mm
Standard Deviation 30.7
|
-68.0 mm
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to and through Week 52Population: Participants who received any amount of study drug and had at least 1 post-baseline physician's global assessment of disease activity; excludes site with GCP issues; LOCF.
Physician's assessment of disease activity using a VAS that ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in disease activity score indicated an improvement in the participant's condition.
Outcome measures
| Measure |
60 mg LY2127399
n=58 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
n=120 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
n=1 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Physician's Global Assessment of Disease Activity (Individual Component of the ACR Core Set)
|
-29.1 mm
Standard Deviation 23.6
|
-18.4 mm
Standard Deviation 26.9
|
-38.0 mm
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to and through Week 52Population: Participants who received any amount of study drug and had at least 1 post-baseline HAQ-DI assessment; excludes site with GCP issues; LOCF.
The disability section of the health assessment questionnaire scored the participant's self-perception on the degree of difficulty \[0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)\] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area, which ranged from 0 (no disability) to 3 (severe disability), were averaged to calculate HAQ-DI. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in HAQ-DI score indicated an improvement in the participant's condition.
Outcome measures
| Measure |
60 mg LY2127399
n=59 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
n=118 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
n=1 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index [(HAQ-DI) Individual Component of the ACR Core Set]
|
-0.3 units on a scale
Standard Deviation 0.5
|
-0.3 units on a scale
Standard Deviation 0.6
|
-0.5 units on a scale
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to and through Week 52Population: Participants who received any amount of study drug and had at least 1 post-baseline self-rated assessment of joint pain; excludes site with GCP issues; LOCF.
Participant's assessment of joint pain using a VAS, which ranged from 0 mm (no pain) to 100 mm (worst possible pain). Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in joint pain indicated an improvement in the participant's condition.
Outcome measures
| Measure |
60 mg LY2127399
n=59 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
n=118 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
n=1 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Participant's Assessment of Joint Pain (Individual Component of the ACR Core Set)
|
-26.9 mm
Standard Deviation 26.4
|
-13.4 mm
Standard Deviation 30.2
|
-68.0 mm
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to and through Week 52Population: Participants who received any amount of study drug and had at least 1 post-baseline CRP assessment; excludes site with GCP issues; LOCF.
CRP is an indicator of inflammation. The percentage of change in CRP from baseline=\[(post-baseline CRP-baseline CRP)/baseline CRP\]\*100. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A negative change indicated an improvement in the participant's condition.
Outcome measures
| Measure |
60 mg LY2127399
n=58 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
n=120 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
n=1 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in C-Reactive Protein [(CRP) Individual Component of the ACR Core Set]
|
-11.1 percent change
Standard Deviation 164.6
|
50.7 percent change
Standard Deviation 214.4
|
241.4 percent change
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to and through Week 52Population: Participants who received any amount of study drug and had at least 1 post-baseline ACR20 assessment; excludes site with GCP issues; missing data imputed by NRI/LOCF. Four (4), 29, and 1 participants were imputed as non-responders for the 60 mg, 60/120 mg, and 60/120/60 mg LY2127399 groups, respectively.
ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had ≥20% improvement from baseline in both tender and swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR20 response=(number of ACR20 responders/number of participants treated)\*100. Participants who discontinued from study prior to Week 52 were imputed as non-responders. Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF. This composite data imputation was denoted as non-responder imputation (NRI)/LOCF. Baseline: the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
Outcome measures
| Measure |
60 mg LY2127399
n=59 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
n=120 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
n=1 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving ACR20 Response
|
66.1 percentage of participants
Interval 52.6 to 77.9
|
32.5 percentage of participants
Interval 24.2 to 41.7
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to and through Week 52Population: Participants who received any amount of study drug and had at least 1 post-baseline ACR50 assessment; excludes site with GCP issues; missing data imputed by NRI/LOCF. Four (4), 29, and 1 participants were imputed as non-responders for the 60 mg, 60/120 mg, and 60/120/60 mg LY2127399 groups, respectively.
ACR50 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR50 Responder: had ≥50% improvement from baseline in both tender and swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR50 response=(number of ACR50 responders/number of participants treated)\*100. Participants who discontinued from study prior to Week 52 were imputed as non-responders. Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF. This composite data imputation was denoted as NRI/LOCF. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
Outcome measures
| Measure |
60 mg LY2127399
n=59 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
n=120 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
n=1 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants ACR50 Response
|
33.9 percentage of participants
|
13.3 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to and through Week 52Population: Participants who received any amount of study drug and had at least 1 post-baseline ACR70 assessment; excludes site with GCP issues; missing data imputed by NRI/LOCF. Four (4), 29, and 1 participants were imputed as non-responders for the 60 mg, 60/120 mg, and 60/120/60 mg LY2127399 groups, respectively.
ACR70 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR70 Responder: had ≥70% improvement from baseline in both tender and swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR70 response=(number of ACR70 responders/number of participants treated)\*100. Participants who discontinued from study prior to Week 52 were imputed as non-responders. Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF. This composite data imputation was denoted as NRI/LOCF. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
Outcome measures
| Measure |
60 mg LY2127399
n=59 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
n=120 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
n=1 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving ACR70 Response
|
18.6 percentage of participants
|
6.7 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to and through Week 52Population: Participants who received any amount of study drug and had at least 1 post-baseline ACR-N assessment; excludes site with GCP issues; LOCF. No participant was analyzed in the 60/120/60 mg LY2127399 treatment arm.
The ACR-N Responder Index was a composite of clinical, laboratory, and functional measures of rheumatoid arthritis. This index was defined as the lowest of either a) percent change in tender joint count, b) percent change in swollen joint count, or c) median percent change in 5 core ACR criteria: participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. For example, a participant with an ACR-N of X had an improvement ≥X% in both tender and swollen joint counts and a median improvement ≥X% in the 5 criteria previously mentioned. Baseline was the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. Results for the 60/120/60 mg LY2127399 treatment arm were not analyzed as the participant did not have an ACR assessment.
Outcome measures
| Measure |
60 mg LY2127399
n=59 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
n=120 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
ACR-N Response
|
31.9 units on a scale
Standard Deviation 47.6
|
11.3 units on a scale
Standard Deviation 46.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to and through Week 52Population: Participants who received any amount of study drug and had at least 1 post-baseline FACIT assessment; excludes site with GCP issues; LOCF.
The FACIT Fatigue Scale was a brief participant-reported measure of fatigue and consisted of 13 items. Scores ranged from 0 to 52, where higher scores indicated less fatigue. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. An increase in FACIT fatigue score indicated an improvement of the participant's condition.
Outcome measures
| Measure |
60 mg LY2127399
n=59 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
n=118 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
n=1 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score
|
5.2 units on a scale
Standard Deviation 10.4
|
5.1 units on a scale
Standard Deviation 10.5
|
-6.0 units on a scale
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to and through Week 52Population: Participants who received any amount of study drug and had at least 1 post-baseline DAS28 assessment; excludes site with GCP issues; LOCF.
The DAS28 consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP (milligrams per liter \[mg/L\]), and participant global assessment of his or her disease activity using a VAS (participant global VAS). The DAS28 was calculated by using the following formula: DAS28-CRP=0.56\*square root(TJC28)+0.28\*square root(SJC28)+0.36\*natural log(CRP+1)+0.014\*participant global VAS+0.96. Scores ranged from 1.0 to 9.4 where lower scores indicated less disease activity and remission is DAS28 \<2.6. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in DAS28 indicated an improvement in the participant's condition.
Outcome measures
| Measure |
60 mg LY2127399
n=56 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
n=117 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
n=1 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28)
|
-2.0 units on a scale
Standard Deviation 1.5
|
-1.3 units on a scale
Standard Deviation 1.5
|
-1.3 units on a scale
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to and through Week 52Population: Participants who received any amount of study drug and had at least 1 post-baseline EULAR28 assessment; excludes site with GCP issues; LOCF.
EULAR28 was defined by the participant's change from baseline in DAS28 score and the absolute DAS28 score achieved. DAS28 consisted of composite score of the following: tender joint count, swollen joint count, CRP, and participant global assessment of his\\her disease activity (participant global VAS). EULAR28 categories included: No Response \[improvement in DAS28 ≤0.6 units (u) or post-baseline DAS28 score \>5.1 with improvement ≤1.2 u\], Moderate Response (post-baseline DAS28 score ≤5.1 with improvement \>0.6 u but \<1.2 u or post-baseline DAS28 score \>3.2 with improvement \>1.2 u), and Good Response (post-baseline DAS28 score ≤3.2 with improvement \>1.2 u). Baseline was the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. Percentage of participants=(number of participants with specific response/participants assessed)\*100. Displayed percentages may not add up to 100% because of rounding.
Outcome measures
| Measure |
60 mg LY2127399
n=56 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
n=117 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
n=1 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Response Based on European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28)
No response
|
16.1 percentage of participants
|
44.4 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Response Based on European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28)
Moderate response
|
48.2 percentage of participants
|
39.3 percentage of participants
|
100.0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Response Based on European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28)
Good response
|
35.7 percentage of participants
|
16.2 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to and through Week 52Population: Participants who received any amount of study drug and had at least 1 post-baseline SF-36 assessment; excludes site with GCP issues; LOCF.
SF-36 was a 36-item, health-related survey that assessed participant's quality of life on 8 domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health, mental health, social functioning, vitality and 2 component scores (mental and physical health). Domain scores calculated by summing individual items for each domain and transforming scores into 0 to 100 scale; higher scores indicated better health status. The mental component summary (MCS) score, based on SF-36 domains, consisted of social functioning, vitality, mental health, and role-emotional scales (range: 0 to 100). The physical component summary (PCS) score, based on SF-36 domains, consisted of physical functioning, bodily pain, role-physical, and general health scales (range: 0 to 100). Baseline: last assessment prior to participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
Outcome measures
| Measure |
60 mg LY2127399
n=59 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
n=117 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
n=1 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores
Physical Health Component Summary Score
|
5.7 units on a scale
Standard Deviation 8.0
|
4.1 units on a scale
Standard Deviation 9.6
|
1.4 units on a scale
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
—
|
—
|
—
|
|
Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores
Mental Health Component Summary Score
|
4.7 units on a scale
Standard Deviation 12.2
|
2.9 units on a scale
Standard Deviation 10.1
|
-2.9 units on a scale
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 52, 60, 72, 80, 88, and 100Population: Participants who received any amount of study drug and a post-baseline total B cell assessment at the specified time points.
B-lymphocyte antigen CD20+ is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928). A negative change indicated a decrease in cell count.
Outcome measures
| Measure |
60 mg LY2127399
n=53 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
n=83 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
n=1 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Pharmacodynamics: Change From Baseline in Total B Cells [Cluster Designation 20+ (CD20+)] Absolute Cell Counts
Week 88
|
-109.9 cells per microliter (cells/µL)
Standard Deviation 83.8
|
-148.6 cells per microliter (cells/µL)
Standard Deviation 131.3
|
-143.0 cells per microliter (cells/µL)
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Total B Cells [Cluster Designation 20+ (CD20+)] Absolute Cell Counts
Week 52
|
-113.1 cells per microliter (cells/µL)
Standard Deviation 103.4
|
-110.3 cells per microliter (cells/µL)
Standard Deviation 121.7
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Total B Cells [Cluster Designation 20+ (CD20+)] Absolute Cell Counts
Week 60
|
-135.9 cells per microliter (cells/µL)
Standard Deviation 119.0
|
-143.1 cells per microliter (cells/µL)
Standard Deviation 135.3
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Total B Cells [Cluster Designation 20+ (CD20+)] Absolute Cell Counts
Week 72
|
-141.0 cells per microliter (cells/µL)
Standard Deviation 105.4
|
-151.6 cells per microliter (cells/µL)
Standard Deviation 117.8
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Total B Cells [Cluster Designation 20+ (CD20+)] Absolute Cell Counts
Week 80
|
-137.6 cells per microliter (cells/µL)
Standard Deviation 85.7
|
-150.9 cells per microliter (cells/µL)
Standard Deviation 127.7
|
-262.0 cells per microliter (cells/µL)
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Total B Cells [Cluster Designation 20+ (CD20+)] Absolute Cell Counts
Week 100
|
-71.7 cells per microliter (cells/µL)
Standard Deviation 68.7
|
-127.3 cells per microliter (cells/µL)
Standard Deviation 121.4
|
-95.0 cells per microliter (cells/µL)
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 52, 60, 72, 80, 88, and 100Population: Participants who received any amount of study drug and had the specified peripheral blood B cell subset assessment post-baseline at the specified time points.
Cell surface marker CD19, CD27, and immunoglobulin D (IgD) expression levels were used to define the various B cell subsets. Cell surface markers were defined as being either present (+) or absent (-). Peripheral blood B cell subsets included: mature naive cells (CD19+IgD+CD27-); immature/transitional cells (CD19+IgD-CD27-); switched memory (CD19+IgD-CD27+); and non-switched memory (CD19+IgD+CD27+). Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928). A negative change indicated a decrease in cell count.
Outcome measures
| Measure |
60 mg LY2127399
n=52 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
n=82 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
n=1 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Non-Switched Memory Cells, Week 52
|
6.0 cells/µL
Standard Deviation 22.0
|
8.3 cells/µL
Standard Deviation 22.2
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Non-Switched Memory Cells, Week 60
|
-3.8 cells/µL
Standard Deviation 2.2
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Non-Switched Memory Cells, Week 72
|
-10.5 cells/µL
Standard Deviation 18.0
|
-7.3 cells/µL
Standard Deviation 18.7
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Non-Switched Memory Cells, Week 80
|
-4.0 cells/µL
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
-3.6 cells/µL
Standard Deviation 4.3
|
-35.0 cells/µL
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Non-Switched Memory Cells, Week 88
|
-18.0 cells/µL
Standard Deviation 17.0
|
-8.2 cells/µL
Standard Deviation 9.7
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Mature Naive Cells, Week 52
|
-115.0 cells/µL
Standard Deviation 79.9
|
-109.2 cells/µL
Standard Deviation 92.2
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Mature Naive Cells, Week 60
|
-138.8 cells/µL
Standard Deviation 67.1
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Mature Naive Cells, Week 72
|
-95.9 cells/µL
Standard Deviation 75.4
|
-102.6 cells/µL
Standard Deviation 90.4
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Mature Naive Cells, Week 80
|
-189.0 cells/µL
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
-80.1 cells/µL
Standard Deviation 62.8
|
-123.0 cells/µL
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Mature Naive Cells, Week 88
|
-116.5 cells/µL
Standard Deviation 99.7
|
-111.7 cells/µL
Standard Deviation 75.5
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Mature Naive Cells, Week 100
|
—
|
-89.0 cells/µL
Standard Deviation 108.9
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Immature/Transitional Cells, Week 52
|
-5.8 cells/µL
Standard Deviation 7.10
|
-4.5 cells/µL
Standard Deviation 13.2
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Immature/Transitional Cells, Week 60
|
-6.5 cells/µL
Standard Deviation 7.9
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Immature/Transitional Cells, Week 72
|
-8.6 cells/µL
Standard Deviation 8.9
|
-8.5 cells/µL
Standard Deviation 15.5
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Immature/Transitional Cells, Week 80
|
-5.0 cells/µL
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
-9.0 cells/µL
Standard Deviation 12.1
|
-10.0 cells/µL
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Immature/Transitional Cells, Week 88
|
-3.0 cells/µL
Standard Deviation 4.2
|
-9.0 cells/µL
Standard Deviation 10.5
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Immature/Transitional Cells, Week 100
|
—
|
-6.5 cells/µL
Standard Deviation 0.7
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Switched Memory Cells, Week 52
|
12.6 cells/µL
Standard Deviation 27.1
|
13.1 cells/µL
Standard Deviation 31.4
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Switched Memory Cells, Week 60
|
-6.5 cells/µL
Standard Deviation 16.3
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Switched Memory Cells, Week 72
|
-14.7 cells/µL
Standard Deviation 18.9
|
-17.7 cells/µL
Standard Deviation 36.1
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Switched Memory Cells, Week 80
|
-10.0 cells/µL
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
-7.5 cells/µL
Standard Deviation 17.3
|
-23.0 cells/µL
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Switched Memory Cells, Week 88
|
-10.0 cells/µL
Standard Deviation 5.7
|
-9.0 cells/µL
Standard Deviation 10.2
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Switched Memory Cells, Week 100
|
—
|
-13.0 cells/µL
Standard Deviation 22.6
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Non-Switched Memory Cells, Week 100
|
—
|
-10.5 cells/µL
Standard Deviation 9.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to Week 52Population: Participants who received any amount of study drug and had at least 1 post-baseline serum immunoglobulin assessment; LOCF.
Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin G (IgG), immunoglobulin M (IgM), and immunoglobulin A (IgA) levels are reported. Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928). A negative change indicated a decrease in immunoglobulin levels.
Outcome measures
| Measure |
60 mg LY2127399
n=59 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
n=121 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
n=1 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Pharmacodynamics: Change From Baseline in Serum Immunoglobulin
IgG
|
-1.8 grams per liter (g/L)
Standard Deviation 2.1
|
-2.0 grams per liter (g/L)
Standard Deviation 3.8
|
-1.9 grams per liter (g/L)
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Serum Immunoglobulin
IgM
|
-0.3 grams per liter (g/L)
Standard Deviation 0.4
|
-0.3 grams per liter (g/L)
Standard Deviation 0.5
|
-0.2 grams per liter (g/L)
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
—
|
—
|
—
|
|
Pharmacodynamics: Change From Baseline in Serum Immunoglobulin
IgA
|
-0.6 grams per liter (g/L)
Standard Deviation 0.8
|
-0.5 grams per liter (g/L)
Standard Deviation 0.7
|
-0.8 grams per liter (g/L)
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Participants who received any amount of study drug and had Week 52 post-baseline RF level assessment, excluding the site with GCP issues. No participant was analyzed in the 60/120/60 mg LY2127399 treatment arm.
RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. Higher RF levels indicate an aggressive rheumatoid arthritis and a higher risk of joint damage. Baseline was defined as Week 0 in this study \[which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)\]. A decrease in RF levels indicated an improvement in the participant's condition. Results for the 60/120/60 mg LY2127399 treatment arm were not analyzed as the participant did not have a Week 52 RF level assessment.
Outcome measures
| Measure |
60 mg LY2127399
n=50 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
n=87 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Pharmacodynamics: Change From Baseline in Rheumatoid Factor (RF) Levels at Week 52
|
-26.9 international units/milliliter (IU/mL)
Standard Deviation 241.4
|
-53.8 international units/milliliter (IU/mL)
Standard Deviation 312.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to Week 52Population: Participants who received any amount of study drug and had at least 1 post-baseline anti-CCP assessment, excluding site with GCP issues; LOCF.
Anti-CCP antibodies were measured using an enzyme-linked immunosorbent assay (ELISA) method. In general, high levels of the antibody indicated an aggressive rheumatoid arthritis and a higher risk of joint damage. Baseline was defined as Week 0 in this study \[which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)\]. A decrease in anti-CCP antibodies indicated an improvement in the participant's condition.
Outcome measures
| Measure |
60 mg LY2127399
n=52 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
n=113 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
n=1 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Pharmacodynamics: Change From Baseline in Serum Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies
|
6.9 units per milliliter (U/mL)
Standard Deviation 241.9
|
-19.4 units per milliliter (U/mL)
Standard Deviation 358.7
|
0.0 units per milliliter (U/mL)
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to Week 52Population: Participants who received any amount of study drug and had at least 1 post-baseline ESR assessment, excluding site with GCP issues; LOCF.
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube. Normal range was considered to be 0 to 20 or 0 to 30 millimeters per hour (mm/h), depending on the reference range used by the laboratory. Higher scores indicated greater inflammation. Percent change from baseline ESR=\[(post-baseline ESR- baseline ESR)/baseline ESR\]\*100. Baseline was defined as Week 0 in this study \[which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)\]. A decrease in ESR indicated an improvement in the participant's condition.
Outcome measures
| Measure |
60 mg LY2127399
n=57 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
n=116 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
n=1 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Pharmacodynamics: Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
|
5.0 percent change
Standard Deviation 63.7
|
20.9 percent change
Standard Deviation 103.9
|
-25.0 percent change
Standard Deviation NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post-study treatment follow-up (start of Week 53 or ED up to and through Week 112)Population: Participants who received any amount of study drug.
The number of participants who had treatment-emergent or follow-up emergent anti-LY2127399 antibodies \[anti-drug antibodies (ADA)\] is reported. Treatment-emergent was defined as participants who had any sample from baseline through Week 52 that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Follow-up emergent was defined as any sample during follow-up that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer. The number of participants with baseline positive ADA data is also reported. Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928).
Outcome measures
| Measure |
60 mg LY2127399
n=60 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
n=121 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
n=1 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Number of Participants With LY2127399 Immunogenicity (Anti-LY2127399 Antibodies)
Baseline Positive ADA
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With LY2127399 Immunogenicity (Anti-LY2127399 Antibodies)
Treatment-Emergent ADA
|
6 Participants
|
15 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With LY2127399 Immunogenicity (Anti-LY2127399 Antibodies)
Follow-Up Emergent ADA
|
2 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post-study treatment follow-up (start of Week 53 or ED up to and through Week 72 and start of Week 73 up to and through Week 112)Population: Participants who received any amount of study drug.
A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. Baseline was defined as Week 0 in this study \[which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)\]. Participants were on treatment up to 48 weeks. If a participant completed 48 weeks of treatment, the post-study treatment follow-up started at the next visit, 4 weeks later (Week 52). If a participant discontinued treatment early, the post-study treatment follow-up started immediately afterwards. After treatment discontinuation, participants could be followed beyond Week 72 for B cell recovery (up to Week 112).
Outcome measures
| Measure |
60 mg LY2127399
n=60 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399
n=121 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399
n=1 Participants
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Died, Any Cause
Died on study treatment [up to Week (Wk) 52]
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Died, Any Cause
Died post-study treatment Wk 53/ED through Wk 72
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Died, Any Cause
Died post-study treatment Wk 73 through Wk 100
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
Adverse Events
60 mg LY2127399 Treatment
Serious events: 4 serious events
Other events: 36 other events
Deaths: 0 deaths
60/120 mg LY2127399 Treatment
Serious events: 16 serious events
Other events: 93 other events
Deaths: 0 deaths
60/120/60 mg LY2127399 Treatment
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
60 mg LY2127399 Post-Study Treatment Follow-Up
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
60/120 mg LY2127399 Post-Study Treatment Follow-Up
Serious events: 4 serious events
Other events: 47 other events
Deaths: 0 deaths
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
60 mg LY2127399 Treatment
n=60 participants at risk
AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit).
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399 Treatment
n=121 participants at risk
AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit).
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399 Treatment
n=1 participants at risk
AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit).
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
n=60 participants at risk
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
n=121 participants at risk
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
n=1 participants at risk
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
100.0%
1/1 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Cardiac disorders
HYPERTROPHIC CARDIOMYOPATHY
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
General disorders
DEVICE DISLOCATION
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
HEPATITIS A
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
INTERVERTEBRAL DISCITIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
OSTEOMYELITIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
PNEUMONIA NECROTISING
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
PSOAS ABSCESS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
BRAIN CONTUSION
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
TRACHEAL OBSTRUCTION
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
3.3%
4/121 • Number of events 4 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN LUNG NEOPLASM
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER METASTATIC
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN EPITHELIAL CANCER
|
0.00%
0/51 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/99 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
2.0%
1/51 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/99 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
100.0%
1/1 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY FIBROSIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Respiratory, thoracic and mediastinal disorders
RHEUMATOID LUNG
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Vascular disorders
ARTERIOSCLEROSIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
Other adverse events
| Measure |
60 mg LY2127399 Treatment
n=60 participants at risk
AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit).
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
|
60/120 mg LY2127399 Treatment
n=121 participants at risk
AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit).
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
|
60/120/60 mg LY2127399 Treatment
n=1 participants at risk
AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit).
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
|
60 mg LY2127399 Post-Study Treatment Follow-Up
n=60 participants at risk
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120 mg LY2127399 Post-Study Treatment Follow-Up
n=121 participants at risk
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
60/120/60 mg LY2127399 Post-Study Treatment Follow-Up
n=1 participants at risk
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
3.3%
2/60 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
5.8%
7/121 • Number of events 7 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Blood and lymphatic system disorders
MICROCYTIC ANAEMIA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Cardiac disorders
BUNDLE BRANCH BLOCK LEFT
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Cardiac disorders
PALPITATIONS
|
3.3%
2/60 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Cardiac disorders
SPLINTER HAEMORRHAGES
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Cardiac disorders
TACHYCARDIA
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Cardiac disorders
VENTRICULAR EXTRASYSTOLES
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Ear and labyrinth disorders
CERUMEN IMPACTION
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Ear and labyrinth disorders
EXTERNAL EAR INFLAMMATION
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Ear and labyrinth disorders
TYMPANIC MEMBRANE PERFORATION
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Eye disorders
CATARACT
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE
|
3.3%
2/60 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Eye disorders
CONJUNCTIVITIS
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Eye disorders
OPEN ANGLE GLAUCOMA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Eye disorders
RETINAL DETACHMENT
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Eye disorders
ULCERATIVE KERATITIS
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
3.3%
2/60 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Gastrointestinal disorders
ABDOMINAL TENDERNESS
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Gastrointestinal disorders
DENTAL CARIES
|
3.3%
2/60 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Gastrointestinal disorders
DIARRHOEA
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
3.3%
2/60 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Gastrointestinal disorders
DYSPHAGIA
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
2.5%
3/121 • Number of events 3 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
100.0%
1/1 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Gastrointestinal disorders
IRRITABLE BOWEL SYNDROME
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
100.0%
1/1 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Gastrointestinal disorders
NAUSEA
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
100.0%
1/1 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Gastrointestinal disorders
ORAL MUCOSAL ERUPTION
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Gastrointestinal disorders
SALIVARY GLAND ENLARGEMENT
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Gastrointestinal disorders
VOMITING
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
General disorders
ASTHENIA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
General disorders
CHEST PAIN
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
General disorders
DRUG INTOLERANCE
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
General disorders
FATIGUE
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
General disorders
INJECTION SITE HAEMORRHAGE
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
General disorders
INJECTION SITE NODULE
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
General disorders
INJECTION SITE PAIN
|
3.3%
2/60 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
9.9%
12/121 • Number of events 12 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
General disorders
INJECTION SITE PARAESTHESIA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
General disorders
INJECTION SITE RASH
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
General disorders
MALAISE
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
General disorders
PYREXIA
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
3.3%
4/121 • Number of events 4 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Hepatobiliary disorders
CHOLESTASIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
ABSCESS LIMB
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
BRONCHIOLITIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
BRONCHITIS
|
10.0%
6/60 • Number of events 7 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
6.6%
8/121 • Number of events 8 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
CONJUNCTIVITIS BACTERIAL
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
CYSTITIS
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
FUNGAL SKIN INFECTION
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
GASTROENTERITIS
|
3.3%
2/60 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
2.5%
3/121 • Number of events 3 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
GASTROINTESTINAL INFECTION
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
HORDEOLUM
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
INFECTED BITES
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
INFLUENZA
|
3.3%
2/60 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
3.3%
4/121 • Number of events 4 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
3.3%
2/60 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
LABYRINTHITIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
LARYNGITIS
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
NASOPHARYNGITIS
|
8.3%
5/60 • Number of events 5 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
7.4%
9/121 • Number of events 9 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
3.3%
4/121 • Number of events 4 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
OTITIS MEDIA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
PHARYNGITIS
|
5.0%
3/60 • Number of events 3 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
4.1%
5/121 • Number of events 6 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
PHARYNGITIS BACTERIAL
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
PHARYNGOTONSILLITIS
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
PNEUMONIA
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
RHINITIS
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
SIALOADENITIS
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
SINUSITIS
|
3.3%
2/60 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
2.5%
3/121 • Number of events 3 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
2.5%
3/121 • Number of events 3 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
SKIN INFECTION
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
SOFT TISSUE INFECTION
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
STAPHYLOCOCCAL PHARYNGITIS
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
STAPHYLOCOCCAL SKIN INFECTION
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
TOOTH ABSCESS
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
TOOTH INFECTION
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
TRACHEITIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
3.3%
2/60 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
9.9%
12/121 • Number of events 12 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
3.3%
2/60 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
URINARY TRACT INFECTION
|
3.3%
2/60 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
10.7%
13/121 • Number of events 13 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
2.5%
3/121 • Number of events 3 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
VAGINAL ABSCESS
|
0.00%
0/51 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/99 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/51 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.0%
1/99 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
VAGINAL INFECTION
|
0.00%
0/51 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.0%
1/99 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/51 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/99 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
2.0%
1/51 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.0%
1/99 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/51 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/99 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
ANAEMIA POSTOPERATIVE
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
ANIMAL BITE
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
CONTUSION
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
DRUG EXPOSURE DURING PREGNANCY
|
0.00%
0/51 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.0%
1/99 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/51 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/99 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
EPICONDYLITIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
EXCORIATION
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
FACIAL BONES FRACTURE
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
FIBULA FRACTURE
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
JOINT SPRAIN
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
LACERATION
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
MUSCLE RUPTURE
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
MUSCLE STRAIN
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
NAIL INJURY
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
TENDON INJURY
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
TENDON RUPTURE
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Injury, poisoning and procedural complications
TOOTH FRACTURE
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Investigations
ASPIRATION JOINT
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Investigations
ASPIRATION PLEURAL CAVITY
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Investigations
B-LYMPHOCYTE COUNT DECREASED
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Investigations
BLOOD CHOLESTEROL INCREASED
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Investigations
BLOOD IMMUNOGLOBULIN M INCREASED
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Investigations
BLOOD PRESSURE INCREASED
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Investigations
BODY TEMPERATURE INCREASED
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Investigations
ECG SIGNS OF VENTRICULAR HYPERTROPHY
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Investigations
ELECTROCARDIOGRAM ST SEGMENT ABNORMAL
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Investigations
HEART RATE INCREASED
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Investigations
NEUTROPHIL COUNT INCREASED
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Investigations
QRS AXIS ABNORMAL
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Investigations
VITAMIN D DECREASED
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Investigations
WEIGHT DECREASED
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Investigations
WEIGHT INCREASED
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
100.0%
1/1 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Metabolism and nutrition disorders
DYSLIPIDAEMIA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Metabolism and nutrition disorders
GOUT
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
100.0%
1/1 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Metabolism and nutrition disorders
HYPERLIPIDAEMIA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
100.0%
1/1 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Metabolism and nutrition disorders
VITAMIN B12 DEFICIENCY
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
3.3%
2/60 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Musculoskeletal and connective tissue disorders
ATLANTOAXIAL INSTABILITY
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
3.3%
2/60 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
4.1%
5/121 • Number of events 5 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Musculoskeletal and connective tissue disorders
ENTHESOPATHY
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Musculoskeletal and connective tissue disorders
EXOSTOSIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Musculoskeletal and connective tissue disorders
FASCIITIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Musculoskeletal and connective tissue disorders
FIBROMYALGIA
|
3.3%
2/60 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Musculoskeletal and connective tissue disorders
FOOT DEFORMITY
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC DEGENERATION
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Musculoskeletal and connective tissue disorders
MYOFASCIAL PAIN SYNDROME
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Musculoskeletal and connective tissue disorders
OSTEOCHONDROSIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
16.7%
10/60 • Number of events 11 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
23.1%
28/121 • Number of events 30 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
5.0%
3/60 • Number of events 3 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
11.6%
14/121 • Number of events 14 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Musculoskeletal and connective tissue disorders
TENDONITIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN NEOPLASM OF THYROID GLAND
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Nervous system disorders
CARPAL TUNNEL SYNDROME
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Nervous system disorders
DIZZINESS
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Nervous system disorders
HEADACHE
|
3.3%
2/60 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
2.5%
3/121 • Number of events 3 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Nervous system disorders
HYPERAESTHESIA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Nervous system disorders
RADICULAR SYNDROME
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Nervous system disorders
VASCULAR DEMENTIA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Nervous system disorders
VITH NERVE PARALYSIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Psychiatric disorders
DEPRESSION
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
3.3%
4/121 • Number of events 4 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
100.0%
1/1 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Renal and urinary disorders
DYSURIA
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Renal and urinary disorders
NEPHROPATHY
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Renal and urinary disorders
RENAL COLIC
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Reproductive system and breast disorders
BREAST CYST
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
2.0%
1/51 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/99 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/51 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/99 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Reproductive system and breast disorders
METRORRHAGIA
|
0.00%
0/51 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/99 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
2.0%
1/51 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/99 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Reproductive system and breast disorders
POSTMENOPAUSAL HAEMORRHAGE
|
0.00%
0/51 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.0%
1/99 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/51 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/99 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Reproductive system and breast disorders
UTERINE POLYP
|
0.00%
0/51 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.0%
1/99 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/51 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/99 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.00%
0/51 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.0%
1/99 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/51 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/99 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC COUGH
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
5.0%
3/60 • Number of events 3 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
2.5%
3/121 • Number of events 3 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Respiratory, thoracic and mediastinal disorders
EMPHYSEMA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Respiratory, thoracic and mediastinal disorders
HYDROPNEUMOTHORAX
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Respiratory, thoracic and mediastinal disorders
RALES
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
2.5%
3/121 • Number of events 3 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ALLERGIC
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Skin and subcutaneous tissue disorders
DERMATOSIS
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Skin and subcutaneous tissue disorders
ECZEMA NUMMULAR
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA NODOSUM
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Skin and subcutaneous tissue disorders
HYPERKERATOSIS
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Skin and subcutaneous tissue disorders
INCREASED TENDENCY TO BRUISE
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Skin and subcutaneous tissue disorders
INGROWING NAIL
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Skin and subcutaneous tissue disorders
MACULE
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Skin and subcutaneous tissue disorders
PETECHIAE
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
2.5%
3/121 • Number of events 3 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Skin and subcutaneous tissue disorders
RASH GENERALISED
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Skin and subcutaneous tissue disorders
RASH PAPULAR
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Skin and subcutaneous tissue disorders
SKIN INDURATION
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Surgical and medical procedures
ARTHRODESIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Surgical and medical procedures
CATARACT OPERATION
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Surgical and medical procedures
DEBRIDEMENT
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Surgical and medical procedures
HIP ARTHROPLASTY
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Surgical and medical procedures
KNEE ARTHROPLASTY
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Surgical and medical procedures
SYNOVECTOMY
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Surgical and medical procedures
TOOTH EXTRACTION
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
2/121 • Number of events 2 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Vascular disorders
AORTIC ARTERIOSCLEROSIS
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Vascular disorders
HAEMATOMA
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Vascular disorders
HOT FLUSH
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Vascular disorders
HYPERTENSION
|
6.7%
4/60 • Number of events 4 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
6.6%
8/121 • Number of events 8 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
100.0%
1/1 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Vascular disorders
PHLEBITIS SUPERFICIAL
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.83%
1/121 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
|
Vascular disorders
VENOUS INSUFFICIENCY
|
0.00%
0/60 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
1.7%
1/60 • Number of events 1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/121 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
0.00%
0/1 • Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60