Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV) (NCT NCT02383589)
NCT ID: NCT02383589
Last Updated: 2020-11-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
135 participants
Primary outcome timeframe
From Baseline up to 52 Weeks (up to clinical cut-off date (CCOD) of 28 November 2018)
Results posted on
2020-11-10
Participant Flow
Participant milestones
| Measure |
Rituximab (RTX)
Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants who withdrew from the treatment period or who completed the total 52-week treatment period entered the safety follow up (SFU) period, and they were observed for 1 year and did not receive any further study treatment.
|
Mycophenolate Mofetil (MMF)
Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants who withdrew from the treatment period or who completed the total 52-week treatment period entered the safety follow up (SFU) period, and they were observed for 1 year and did not receive any further study treatment.
|
|---|---|---|
|
Treatment Period
STARTED
|
67
|
68
|
|
Treatment Period
COMPLETED
|
66
|
58
|
|
Treatment Period
NOT COMPLETED
|
1
|
10
|
|
Safety Follow-up (SFU)
STARTED
|
66
|
58
|
|
Safety Follow-up (SFU)
COMPLETED
|
59
|
53
|
|
Safety Follow-up (SFU)
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
| Measure |
Rituximab (RTX)
Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants who withdrew from the treatment period or who completed the total 52-week treatment period entered the safety follow up (SFU) period, and they were observed for 1 year and did not receive any further study treatment.
|
Mycophenolate Mofetil (MMF)
Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants who withdrew from the treatment period or who completed the total 52-week treatment period entered the safety follow up (SFU) period, and they were observed for 1 year and did not receive any further study treatment.
|
|---|---|---|
|
Treatment Period
Adverse Event
|
1
|
3
|
|
Treatment Period
Lost to Follow-up
|
0
|
1
|
|
Treatment Period
Withdrawal by Subject
|
0
|
5
|
|
Treatment Period
Non-compliance with study drug
|
0
|
1
|
|
Safety Follow-up (SFU)
Lost to Follow-up
|
2
|
4
|
|
Safety Follow-up (SFU)
Withdrawal by Subject
|
5
|
0
|
|
Safety Follow-up (SFU)
Treated by not accepted treatment
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV)
Baseline characteristics by cohort
| Measure |
Rituximab (RTX)
n=67 Participants
Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants who withdrew from the treatment period or who completed the total 52-week treatment period entered the safety follow up (SFU) period, and they were observed for 1 year and did not receive any further study treatment.
|
Mycophenolate Mofetil (MMF)
n=68 Participants
Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants who withdrew from the treatment period or who completed the total 52-week treatment period entered the safety follow up (SFU) period, and they were observed for 1 year and did not receive any further study treatment.
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.66 Years
STANDARD_DEVIATION 12.98 • n=93 Participants
|
46.34 Years
STANDARD_DEVIATION 13.08 • n=4 Participants
|
48.48 Years
STANDARD_DEVIATION 13.16 • n=27 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
73 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
13 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
45 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
86 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Not Stated
|
8 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
14 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
49 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
100 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: From Baseline up to 52 Weeks (up to clinical cut-off date (CCOD) of 28 November 2018)Population: The modified intent-to-treat (mITT) population included participants in the ITT population (all randomized participants who received any part of an infusion of study drug or oral administration of study drug), excluding the 10 telemedicine (TM) participants. This population was used in the analyses of efficacy outcomes.
Outcome measures
| Measure |
Rituximab (RTX)
n=62 Participants
Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
|
Mycophenolate Mofetil (MMF)
n=63 Participants
Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
|
|---|---|---|
|
Percentage of Participants (Excluding Telemedicine [TM] Participants) Who Achieved Sustained Complete Remission, Evaluated by the Pemphigus Disease Area Index (PDAI) Activity Score
|
40.3 Percentage of Participants
|
9.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)Population: The mITT population included participants in the ITT population (all randomized participants who received any part of an infusion of study drug or oral administration of study drug), excluding the 10 TM participants. This population was used in the analyses of efficacy outcomes.
Outcome measures
| Measure |
Rituximab (RTX)
n=62 Participants
Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
|
Mycophenolate Mofetil (MMF)
n=63 Participants
Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
|
|---|---|---|
|
Cumulative Oral Corticosteroid Dose
|
2775.00 milligram (mg)
Interval 2146.88 to 3610.0
|
4005.00 milligram (mg)
Interval 2662.5 to 5815.0
|
SECONDARY outcome
Timeframe: From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)Population: The mITT population included participants in the ITT population (all randomized participants who received any part of an infusion of study drug or oral administration of study drug), excluding the 10 TM participants. This population was used in the analyses of efficacy outcomes.
Disease flare is defined as appearance of three or more new lesions a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who has achieved disease control.
Outcome measures
| Measure |
Rituximab (RTX)
n=62 Participants
Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
|
Mycophenolate Mofetil (MMF)
n=63 Participants
Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
|
|---|---|---|
|
Total Number of Protocol Defined Disease Flares
|
6 Number of Flares
|
44 Number of Flares
|
SECONDARY outcome
Timeframe: From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)Population: The mITT population included participants in the ITT population (all randomized participants who received any part of an infusion of study drug or oral administration of study drug), excluding the 10 TM participants. This population was used in the analyses of efficacy outcomes.
Outcome measures
| Measure |
Rituximab (RTX)
n=62 Participants
Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
|
Mycophenolate Mofetil (MMF)
n=63 Participants
Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
|
|---|---|---|
|
Time to Initial Sustained Complete Remission
|
NA Weeks
Interval 32.1 to
The median is not estimable due to limited number of events
|
NA Weeks
The median is not estimable due to limited number of events
|
SECONDARY outcome
Timeframe: From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)Population: The mITT population included participants in the ITT population (all randomized participants who received any part of an infusion of study drug or oral administration of study drug), excluding the 10 TM participants. This population was used in the analyses of efficacy outcomes.
Disease flare is defined as the appearance of three or more new lesions a month that do not heal spontaneously within 1 week or by the extension of established lesions in a participant who has achieved disease control.
Outcome measures
| Measure |
Rituximab (RTX)
n=62 Participants
Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
|
Mycophenolate Mofetil (MMF)
n=63 Participants
Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
|
|---|---|---|
|
Time to Protocol Defined Disease Flare
|
NA Weeks
The median is not estimable due to limited number of events
|
NA Weeks
Interval 36.9 to
The median is not estimable due to limited number of events
|
SECONDARY outcome
Timeframe: From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)Population: The mITT population included participants in the ITT population (all randomized participants who received any part of an infusion of study drug or oral administration of study drug), excluding the 10 TM participants. This population was used in the analyses of efficacy outcomes. Only participants for whom data were collected are included in the analysis.
Total DLQI scores range from 0 to 30 with higher DLQI scores reflecting greater impairment in a participant's health-related quality of life. The DLQI score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The measure type mean is the estimated mean from adjusted MMRM.
Outcome measures
| Measure |
Rituximab (RTX)
n=62 Participants
Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
|
Mycophenolate Mofetil (MMF)
n=63 Participants
Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
|
|---|---|---|
|
Change in Health-Related Quality of Life (HRQoL), as Measured by the Dermatology Life Quality Index (DLQI) Score
Baseline
|
10.14 Scores on a Scale
Standard Error 7.89
|
11.09 Scores on a Scale
Standard Error 8.52
|
|
Change in Health-Related Quality of Life (HRQoL), as Measured by the Dermatology Life Quality Index (DLQI) Score
Week 52
|
-8.874 Scores on a Scale
Standard Error 0.532
|
-6.002 Scores on a Scale
Standard Error 0.662
|
SECONDARY outcome
Timeframe: Baseline up to 52 Weeks (up to CCOD of 28 November 2018)Population: The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug.
An adverse event is any untoward medical occurrence in a participant to whom a medicinal product is administered and which does not necessarily have a causal relationship with this treatment. A serious adverse event is an adverse event that results in death or is life-threatening or requires/prolongs hospitalization or results in persistent/significant disability/incapacity or congenital abnormality/birth defect. Adverse events of Grade 3 of higher are severe and life-threatening adverse events CS-related adverse events - causality as determined by the investigator.
Outcome measures
| Measure |
Rituximab (RTX)
n=67 Participants
Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
|
Mycophenolate Mofetil (MMF)
n=68 Participants
Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
|
|---|---|---|
|
Percentage of Participants With Adverse Events, Serious Adverse Events, and Corticosteroid-Related Adverse Events
Participants with AE
|
85.1 Percentage of Participants
|
88.2 Percentage of Participants
|
|
Percentage of Participants With Adverse Events, Serious Adverse Events, and Corticosteroid-Related Adverse Events
Participants with SAE
|
22.4 Percentage of Participants
|
14.7 Percentage of Participants
|
|
Percentage of Participants With Adverse Events, Serious Adverse Events, and Corticosteroid-Related Adverse Events
Participants with Corticosteroid (CS)-Related AE
|
34.3 Percentage of Participants
|
38.2 Percentage of Participants
|
|
Percentage of Participants With Adverse Events, Serious Adverse Events, and Corticosteroid-Related Adverse Events
Participants with CS-Related AE Grade 3 or higher
|
1.5 Percentage of Participants
|
7.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline up to 52 Weeks (up to CCOD of 28 November 2018)Population: The safety population (all participants who were randomized and received any part of an infusion of study drug), only participants for whom data were collected are included in the analysis.
Participants with treatment-induced and treatment-enhanced anti-drug antibodies. The clinical relevance of anti-rituximab antibody formation in RITUXAN treated pemphigus vulgaris (PV) participants is unclear.
Outcome measures
| Measure |
Rituximab (RTX)
n=67 Participants
Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
|
Mycophenolate Mofetil (MMF)
Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
|
|---|---|---|
|
Percentage of Participants With Anti-Drug Antibodies (ADA)
|
31.7 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline; Weeks 16, 24, 40 and 52; (end of treatment: up to Week 52) (up to CCOD of 28 November 2018)Population: The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug.
Outcome measures
| Measure |
Rituximab (RTX)
n=67 Participants
Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
|
Mycophenolate Mofetil (MMF)
n=68 Participants
Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
|
|---|---|---|
|
Percentage of Participants With Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN)
Baseline (IgA)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN)
Week 16 (IgA)
|
0 Percentage of Participants
|
1.8 Percentage of Participants
|
|
Percentage of Participants With Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN)
Week 24 (IgA)
|
1.7 Percentage of Participants
|
2.2 Percentage of Participants
|
|
Percentage of Participants With Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN)
Week 40 (IgA)
|
0 Percentage of Participants
|
2.7 Percentage of Participants
|
|
Percentage of Participants With Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN)
Week 52 (IgA)
|
0 Percentage of Participants
|
3.6 Percentage of Participants
|
|
Percentage of Participants With Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN)
Baseline (IgG)
|
6.1 Percentage of Participants
|
6.0 Percentage of Participants
|
|
Percentage of Participants With Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN)
Week 16 (IgG)
|
9.8 Percentage of Participants
|
1.8 Percentage of Participants
|
|
Percentage of Participants With Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN)
Week 24 (IgG)
|
3.4 Percentage of Participants
|
2.2 Percentage of Participants
|
|
Percentage of Participants With Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN)
Week 40 (IgG)
|
3.5 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN)
Week 52 (IgG)
|
4.3 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN)
Baseline (IgM)
|
7.6 Percentage of Participants
|
11.9 Percentage of Participants
|
|
Percentage of Participants With Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN)
Week 16 (IgM)
|
24.6 Percentage of Participants
|
23.2 Percentage of Participants
|
|
Percentage of Participants With Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN)
Week 24 (IgM)
|
27.1 Percentage of Participants
|
28.3 Percentage of Participants
|
|
Percentage of Participants With Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN)
Week 40 (IgM)
|
29.8 Percentage of Participants
|
24.3 Percentage of Participants
|
|
Percentage of Participants With Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN)
Week 52 (IgM)
|
29.8 Percentage of Participants
|
28.6 Percentage of Participants
|
Adverse Events
RTX Safety Follow-up
Serious events: 4 serious events
Other events: 2 other events
Deaths: 0 deaths
Rituximab (RTX)
Serious events: 15 serious events
Other events: 42 other events
Deaths: 0 deaths
Mycophenolate Mofetil (MMF)
Serious events: 10 serious events
Other events: 41 other events
Deaths: 1 deaths
MMF Safety Follow-up
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RTX Safety Follow-up
n=66 participants at risk
Participants, who received RTX in the treatment period, and either withdrew from the treatment period or completed the total 52-week treatment period, entered the SFU period. Participants were observed for 1 year and did not receive any further study treatment.
|
Rituximab (RTX)
n=67 participants at risk
Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
|
Mycophenolate Mofetil (MMF)
n=68 participants at risk
Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
|
MMF Safety Follow-up
n=58 participants at risk
Participants, who received MMF in the treatment period, and either withdrew from the treatment period or completed the total 52-week treatment period, entered the SFU period. Participants were observed for 1 year and did not receive any further study treatment.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/67 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
2.9%
2/68 • Number of events 2 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/67 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/68 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/67 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/68 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/67 • Number of events 2 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/68 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/67 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/68 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Gastrointestinal disorders
ILEUS
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/67 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/68 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Gastrointestinal disorders
INCARCERATED UMBILICAL HERNIA
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/67 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/68 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Infections and infestations
BURSITIS INFECTIVE
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/67 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/68 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/67 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/68 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/67 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/68 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/67 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/68 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/67 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/68 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Infections and infestations
PNEUMONIA VIRAL
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/67 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/68 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/67 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/68 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/67 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/68 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/67 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/68 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/67 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/68 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/67 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/68 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
4.5%
3/67 • Number of events 3 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/68 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/67 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/68 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Injury, poisoning and procedural complications
PELVIC FRACTURE
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/67 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/68 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SMALL CELL LUNG CANCER
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/67 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/68 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/67 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/68 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/67 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/68 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/67 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/68 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/67 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/68 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/67 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/68 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
1.5%
1/66 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/67 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/68 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Infections and infestations
Septic shock
|
1.5%
1/66 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/67 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/68 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.5%
1/66 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/67 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/68 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.5%
1/66 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/67 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/68 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Nervous system disorders
Syncope
|
1.5%
1/66 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/67 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/68 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Skin and subcutaneous tissue disorders
Neutrophilic dermatosis
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/67 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/68 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.7%
1/58 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
Other adverse events
| Measure |
RTX Safety Follow-up
n=66 participants at risk
Participants, who received RTX in the treatment period, and either withdrew from the treatment period or completed the total 52-week treatment period, entered the SFU period. Participants were observed for 1 year and did not receive any further study treatment.
|
Rituximab (RTX)
n=67 participants at risk
Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
|
Mycophenolate Mofetil (MMF)
n=68 participants at risk
Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
|
MMF Safety Follow-up
n=58 participants at risk
Participants, who received MMF in the treatment period, and either withdrew from the treatment period or completed the total 52-week treatment period, entered the SFU period. Participants were observed for 1 year and did not receive any further study treatment.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
11.9%
8/67 • Number of events 14 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/68 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
4.5%
3/67 • Number of events 5 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
14.7%
10/68 • Number of events 11 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
3.0%
2/67 • Number of events 4 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
5.9%
4/68 • Number of events 4 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
General disorders
ASTHENIA
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
6.0%
4/67 • Number of events 5 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
5.9%
4/68 • Number of events 4 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
General disorders
FATIGUE
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
7.5%
5/67 • Number of events 8 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
4.4%
3/68 • Number of events 3 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
3.0%
2/67 • Number of events 2 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
8.8%
6/68 • Number of events 8 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
9.0%
6/67 • Number of events 8 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
11.8%
8/68 • Number of events 12 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
9.0%
6/67 • Number of events 8 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
8.8%
6/68 • Number of events 6 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
3.0%
2/66 • Number of events 2 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
9.0%
6/67 • Number of events 9 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
7.4%
5/68 • Number of events 6 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
5.2%
3/58 • Number of events 3 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
7.5%
5/67 • Number of events 6 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
2.9%
2/68 • Number of events 2 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
17.9%
12/67 • Number of events 19 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
7.4%
5/68 • Number of events 6 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
7.5%
5/67 • Number of events 5 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/68 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
9.0%
6/67 • Number of events 6 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
2.9%
2/68 • Number of events 2 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
9.0%
6/67 • Number of events 6 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/68 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
6.0%
4/67 • Number of events 4 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
2.9%
2/68 • Number of events 2 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
14.9%
10/67 • Number of events 17 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
8.8%
6/68 • Number of events 7 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
1.5%
1/67 • Number of events 1 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
8.8%
6/68 • Number of events 6 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
9.0%
6/67 • Number of events 6 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
2.9%
2/68 • Number of events 2 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
6.0%
4/67 • Number of events 4 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
4.4%
3/68 • Number of events 3 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
3.0%
2/67 • Number of events 2 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
7.4%
5/68 • Number of events 5 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/66 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
3.0%
2/67 • Number of events 2 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
5.9%
4/68 • Number of events 4 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
0.00%
0/58 • Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER