Trial Outcomes & Findings for Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (NCT NCT03616821)
NCT ID: NCT03616821
Last Updated: 2026-06-23
Results Overview
Efficacy was assessed using the Mayo Scoring System for assessment of Ulcerative Colitis. The Mayo score assesses * stool frequency, * rectal bleeding, * endoscopic findings, and * physician's assessment of disease activity. Each of these four subscores can be scored as 0, 1, 2, or 3, where 0 is a normal finding and 3 corresponds to severe disease. The Mayo score has been modified (modified Mayo Score, mMS) to specify no friability in the endoscopy subscore of 1 (mild disease). Clinical Remission is defined by the mMS at Week 10: * Endoscopy subscore = 0 or 1, AND * Rectal bleeding subscore = 0, AND * Stool frequency subscore = 0 or 1, AND at least a 1-point decrease from baseline Further, if the patient * discontinue treatment prematurely for any reason * takes rescue treatment or meet the rescue criteria * uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
242 participants
Primary outcome timeframe
at Week 10
Results posted on
2026-06-23
Participant Flow
As of 1 June 2023, AstraZeneca discontinued the development of brazikumab. All study related dosing was immediately stopped. Because of study early termination, site data cleaning engagement proved challenging and as a result databases were locked with unclean data. A patient centric approach was taken to focus data cleaning on key safety variables (adverse events). Please be aware that the data submitted needs to be considered with the data quality in mind.
Participant milestones
| Measure |
Brazikumab 720 mg
IV brazikumab 720 mg during induction period
|
Brazikumab 1440 mg
IV brazikumab 1440 mg during induction period
|
Brazikumab 2100 mg
IV brazikumab 2100 mg during induction period
|
Vedolizumab
IV vedolizumab 300 mg during induction period and maintenance
|
Placebo
IV placebo during induction period
|
|---|---|---|---|---|---|
|
Induction Period
STARTED
|
73
|
73
|
10
|
10
|
71
|
|
Induction Period
COMPLETED
|
54
|
58
|
9
|
9
|
41
|
|
Induction Period
NOT COMPLETED
|
19
|
15
|
1
|
1
|
30
|
|
Maintenance Period
STARTED
|
48
|
53
|
9
|
9
|
32
|
|
Maintenance Period
COMPLETED
|
11
|
15
|
7
|
5
|
8
|
|
Maintenance Period
NOT COMPLETED
|
37
|
38
|
2
|
4
|
24
|
Reasons for withdrawal
| Measure |
Brazikumab 720 mg
IV brazikumab 720 mg during induction period
|
Brazikumab 1440 mg
IV brazikumab 1440 mg during induction period
|
Brazikumab 2100 mg
IV brazikumab 2100 mg during induction period
|
Vedolizumab
IV vedolizumab 300 mg during induction period and maintenance
|
Placebo
IV placebo during induction period
|
|---|---|---|---|---|---|
|
Induction Period
Adverse Event
|
1
|
0
|
0
|
0
|
1
|
|
Induction Period
Lack of Efficacy
|
4
|
2
|
1
|
0
|
13
|
|
Induction Period
Physician Decision
|
2
|
0
|
0
|
0
|
0
|
|
Induction Period
Protocol Violation
|
0
|
1
|
0
|
0
|
1
|
|
Induction Period
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
3
|
|
Induction Period
Study terminated by sponsor, Site terminated by sponsor, or Other
|
12
|
12
|
0
|
0
|
12
|
|
Maintenance Period
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
|
Maintenance Period
Lack of Efficacy
|
2
|
1
|
0
|
1
|
4
|
|
Maintenance Period
Pregnancy
|
0
|
1
|
0
|
0
|
0
|
|
Maintenance Period
Physician Decision
|
0
|
0
|
0
|
0
|
2
|
|
Maintenance Period
Withdrawal by Subject
|
1
|
1
|
0
|
1
|
3
|
|
Maintenance Period
Study terminated by sponsor, site terminated by sponsor, COVID-19 or Other
|
34
|
34
|
2
|
2
|
15
|
Baseline Characteristics
Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Brazikumab 720 mg
n=65 Participants
IV brazikumab 720 mg during induction period
|
Brazikumab 1440 mg
n=65 Participants
IV brazikumab 1440 mg during induction period
|
Brazikumab 2100 mg
n=10 Participants
IV brazikumab 2100 mg during induction period
|
Vedolizumab 300 mg
n=10 Participants
IV vedolizumab 300 mg during induction period
|
Placebo
n=65 Participants
IV placebo during induction period
|
Total
n=215 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
34 Participants
n=20 Participants
|
28 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
6 Participants
n=5 Participants
|
33 Participants
n=9 Participants
|
107 Participants
n=6 Participants
|
|
Age, Continuous
|
39.4 years
STANDARD_DEVIATION 13.82 • n=20 Participants
|
43.7 years
STANDARD_DEVIATION 13.59 • n=20 Participants
|
51.2 years
STANDARD_DEVIATION 14.95 • n=40 Participants
|
42.9 years
STANDARD_DEVIATION 11.45 • n=5 Participants
|
41.0 years
STANDARD_DEVIATION 14.71 • n=9 Participants
|
41.4 years
STANDARD_DEVIATION 14.09 • n=6 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=20 Participants
|
37 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
4 Participants
n=5 Participants
|
32 Participants
n=9 Participants
|
108 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=9 Participants
|
19 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=20 Participants
|
61 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
8 Participants
n=5 Participants
|
59 Participants
n=9 Participants
|
196 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
15 Participants
n=9 Participants
|
48 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
7 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=20 Participants
|
42 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
7 Participants
n=5 Participants
|
47 Participants
n=9 Participants
|
155 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: at Week 10Population: The efficacy analysis set includes subjects who had completed the induction period at time of study termination, or who would have had the opportunity to complete the induction period at the time of the termination if not prematurely discontinuing IP. The reason for excluding subjects was to avoid bias in the analysis.
Efficacy was assessed using the Mayo Scoring System for assessment of Ulcerative Colitis. The Mayo score assesses * stool frequency, * rectal bleeding, * endoscopic findings, and * physician's assessment of disease activity. Each of these four subscores can be scored as 0, 1, 2, or 3, where 0 is a normal finding and 3 corresponds to severe disease. The Mayo score has been modified (modified Mayo Score, mMS) to specify no friability in the endoscopy subscore of 1 (mild disease). Clinical Remission is defined by the mMS at Week 10: * Endoscopy subscore = 0 or 1, AND * Rectal bleeding subscore = 0, AND * Stool frequency subscore = 0 or 1, AND at least a 1-point decrease from baseline Further, if the patient * discontinue treatment prematurely for any reason * takes rescue treatment or meet the rescue criteria * uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Outcome measures
| Measure |
Brazikumab 720 mg
n=65 Participants
IV brazikumab 720 mg during induction period
|
Brazikumab 1440 mg
n=65 Participants
IV brazikumab 1440 mg during induction period
|
Brazikumab 2100 mg
n=10 Participants
IV brazikumab 2100 mg during induction period
|
Vedolizumab
n=10 Participants
IV vedolizumab 300 mg during induction period
|
Placebo
n=65 Participants
IV placebo during induction period
|
Brazikumab 720 mg/120 mg (Maintenance Period)
IV brazikumab 720 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 720 mg/240 mg (Maintenance Period)
IV brazikumab 720 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 120 mg (Maintenance Period)
IV brazikuamb 1440 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 1440 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 2100 mg/Brazikumab 120 (Maintenance Period)
IV brazikumab 2100 mg during induction period, SC brazikuamb 120 during maintenance
|
Braziumab 2100 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 2100 during induction period SC brazikumab 240 mg during maintenance
|
Vedoliumab 300 mg
IV vedolizumab 300 mg during maintenance
|
Placebo (Maintenance Period)
IV placebo during induction, SC placebo during maintenance
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Clinical Remission
|
13 Participants
|
16 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10 and 54Population: Outcome measure 2 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed for the maintenance period, and adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the mMS total score and components. These are provided in outcome measures 16 - 19 for induction, and 20 - 23 for maintenance.
Sustained clinical remission defined as Modified Mayo Score (mMS): Endoscopy subscore = 0 or 1, AND Rectal bleeding subscore = 0, AND Stool frequency subscore = 0 or 1 AND at least a 1 point decrease from baseline Further, if the patient * discontinue treatment prematurely for any reason * takes rescue treatment or meet the rescue criteria * uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 54Population: Outcome measure 3 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed for the maintenance period, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the Endoscopy, Rectal bleeding and Stool frequency subscores at week 54. These are provided in outcome measures 21 - 23.
CS-free clinical remission defined as mMS: Endoscopy subscore = 0 or 1, AND Rectal bleeding subscore = 0, AND Stool frequency subscore = 0 or 1 AND at least a 1 point decrease from baseline Further, if the patient * discontinue treatment prematurely for any reason * takes rescue treatment or meet the rescue criteria * uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 10Population: The efficacy analysis set includes subjects who had completed the induction period at time of study termination, or who would have had the opportunity to complete the induction period at the time of the termination if not prematurely discontinuing IP. The reason for excluding subjects was to avoid bias in the analysis.
Efficacy was assessed using the Mayo Scoring System for assessment of Ulcerative Colitis. The Mayo score assesses * stool frequency, * rectal bleeding, * endoscopic findings, and * physician's assessment of disease activity. Each of these four subscores can be scored as 0, 1, 2, or 3, where 0 is a normal finding and 3 corresponds to severe disease. The Mayo score is the sum of the four subscores. The Mayo score has been modified (modified Mayo Score, mMS) to specify no friability in the endoscopy subscore of 1 (mild disease). Clinical response is defined as Reduction in mMS ≥ 2 points from baseline AND ≥ 30% from baseline AND a decrease in the rectal bleeding score ≥ 1 point from baseline or a score of 0 or 1 Further, if the patient * discontinue treatment prematurely for any reason * takes rescue treatment or meet the rescue criteria * uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Outcome measures
| Measure |
Brazikumab 720 mg
n=65 Participants
IV brazikumab 720 mg during induction period
|
Brazikumab 1440 mg
n=65 Participants
IV brazikumab 1440 mg during induction period
|
Brazikumab 2100 mg
n=10 Participants
IV brazikumab 2100 mg during induction period
|
Vedolizumab
n=10 Participants
IV vedolizumab 300 mg during induction period
|
Placebo
n=65 Participants
IV placebo during induction period
|
Brazikumab 720 mg/120 mg (Maintenance Period)
IV brazikumab 720 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 720 mg/240 mg (Maintenance Period)
IV brazikumab 720 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 120 mg (Maintenance Period)
IV brazikuamb 1440 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 1440 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 2100 mg/Brazikumab 120 (Maintenance Period)
IV brazikumab 2100 mg during induction period, SC brazikuamb 120 during maintenance
|
Braziumab 2100 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 2100 during induction period SC brazikumab 240 mg during maintenance
|
Vedoliumab 300 mg
IV vedolizumab 300 mg during maintenance
|
Placebo (Maintenance Period)
IV placebo during induction, SC placebo during maintenance
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Clinical Response
|
38 Participants
|
43 Participants
|
6 Participants
|
5 Participants
|
21 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10Population: The efficacy analysis set includes subjects who had completed the induction period at time of study termination, or who would have had the opportunity to complete the induction period at the time of the termination if not prematurely discontinuing IP. The reason for excluding subjects was to avoid bias in the analysis.
Efficacy was assessed using the Mayo Scoring System for assessment of Ulcerative Colitis. The Mayo score assesses * stool frequency, * rectal bleeding, * endoscopic findings, and * physician's assessment of disease activity. Each of these four subscores can be scored as 0, 1, 2, or 3, where 0 is a normal finding and 3 corresponds to severe disease. Endoscopic improvement is defined as Endoscopy subscore ≤ 1. Further, if the patient * discontinue treatment prematurely for any reason * takes rescue treatment or meet the rescue criteria * uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Outcome measures
| Measure |
Brazikumab 720 mg
n=65 Participants
IV brazikumab 720 mg during induction period
|
Brazikumab 1440 mg
n=65 Participants
IV brazikumab 1440 mg during induction period
|
Brazikumab 2100 mg
n=10 Participants
IV brazikumab 2100 mg during induction period
|
Vedolizumab
n=10 Participants
IV vedolizumab 300 mg during induction period
|
Placebo
n=65 Participants
IV placebo during induction period
|
Brazikumab 720 mg/120 mg (Maintenance Period)
IV brazikumab 720 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 720 mg/240 mg (Maintenance Period)
IV brazikumab 720 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 120 mg (Maintenance Period)
IV brazikuamb 1440 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 1440 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 2100 mg/Brazikumab 120 (Maintenance Period)
IV brazikumab 2100 mg during induction period, SC brazikuamb 120 during maintenance
|
Braziumab 2100 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 2100 during induction period SC brazikumab 240 mg during maintenance
|
Vedoliumab 300 mg
IV vedolizumab 300 mg during maintenance
|
Placebo (Maintenance Period)
IV placebo during induction, SC placebo during maintenance
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Endoscopic Improvement
|
20 Participants
|
22 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: through week 10Population: The PK population includes all participants who receive at least 1 dose of study intervention and have at least 1 PK sample containing detectable brazikumab concentrations.
Pharmacokinetics: concentration of brazikumab in serum
Outcome measures
| Measure |
Brazikumab 720 mg
n=73 Participants
IV brazikumab 720 mg during induction period
|
Brazikumab 1440 mg
n=73 Participants
IV brazikumab 1440 mg during induction period
|
Brazikumab 2100 mg
n=10 Participants
IV brazikumab 2100 mg during induction period
|
Vedolizumab
IV vedolizumab 300 mg during induction period
|
Placebo
IV placebo during induction period
|
Brazikumab 720 mg/120 mg (Maintenance Period)
IV brazikumab 720 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 720 mg/240 mg (Maintenance Period)
IV brazikumab 720 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 120 mg (Maintenance Period)
IV brazikuamb 1440 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 1440 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 2100 mg/Brazikumab 120 (Maintenance Period)
IV brazikumab 2100 mg during induction period, SC brazikuamb 120 during maintenance
|
Braziumab 2100 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 2100 during induction period SC brazikumab 240 mg during maintenance
|
Vedoliumab 300 mg
IV vedolizumab 300 mg during maintenance
|
Placebo (Maintenance Period)
IV placebo during induction, SC placebo during maintenance
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum Concentrations of Brazikumab (Induction)
Week 2
|
75291.704 ng/mL
Standard Deviation 31788.795
|
139856.234 ng/mL
Standard Deviation 58752.407
|
155245.114 ng/mL
Standard Deviation 72452.962
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of Brazikumab (Induction)
Week 10
|
72877.126 ng/mL
Standard Deviation 41076.655
|
166348.190 ng/mL
Standard Deviation 104266.602
|
200384.910 ng/mL
Standard Deviation 100905.735
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of Brazikumab (Induction)
Baseline (Week 0)
|
0.0 ng/mL
Standard Deviation 0.0
|
0.0 ng/mL
Standard Deviation 0.0
|
0.0 ng/mL
Standard Deviation 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: through week 68Population: All participants who receive at least 1 dose of study intervention and have at least 1 PK sample containing detectable brazikumab concentrations, and who are part of the Efficacy Analysis Set.
Participants with Clinical Remission by Quartile of Brazikumab concentration
Outcome measures
| Measure |
Brazikumab 720 mg
n=31 Participants
IV brazikumab 720 mg during induction period
|
Brazikumab 1440 mg
n=31 Participants
IV brazikumab 1440 mg during induction period
|
Brazikumab 2100 mg
n=31 Participants
IV brazikumab 2100 mg during induction period
|
Vedolizumab
n=31 Participants
IV vedolizumab 300 mg during induction period
|
Placebo
IV placebo during induction period
|
Brazikumab 720 mg/120 mg (Maintenance Period)
IV brazikumab 720 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 720 mg/240 mg (Maintenance Period)
IV brazikumab 720 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 120 mg (Maintenance Period)
IV brazikuamb 1440 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 1440 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 2100 mg/Brazikumab 120 (Maintenance Period)
IV brazikumab 2100 mg during induction period, SC brazikuamb 120 during maintenance
|
Braziumab 2100 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 2100 during induction period SC brazikumab 240 mg during maintenance
|
Vedoliumab 300 mg
IV vedolizumab 300 mg during maintenance
|
Placebo (Maintenance Period)
IV placebo during induction, SC placebo during maintenance
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Exposure-response
Yes
|
5 Participants
|
7 Participants
|
9 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Exposure-response
No
|
26 Participants
|
24 Participants
|
22 Participants
|
21 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: through week 10Population: The data is reported for the PK population including all participants who receive at least 1 dose of study intervention and have at least 1 PK sample containing detectable brazikumab concentrations.
Immunogenicity: incidence of brazikumab anti-drug antibodies in serum
Outcome measures
| Measure |
Brazikumab 720 mg
n=75 Participants
IV brazikumab 720 mg during induction period
|
Brazikumab 1440 mg
n=73 Participants
IV brazikumab 1440 mg during induction period
|
Brazikumab 2100 mg
n=10 Participants
IV brazikumab 2100 mg during induction period
|
Vedolizumab
IV vedolizumab 300 mg during induction period
|
Placebo
IV placebo during induction period
|
Brazikumab 720 mg/120 mg (Maintenance Period)
IV brazikumab 720 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 720 mg/240 mg (Maintenance Period)
IV brazikumab 720 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 120 mg (Maintenance Period)
IV brazikuamb 1440 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 1440 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 2100 mg/Brazikumab 120 (Maintenance Period)
IV brazikumab 2100 mg during induction period, SC brazikuamb 120 during maintenance
|
Braziumab 2100 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 2100 during induction period SC brazikumab 240 mg during maintenance
|
Vedoliumab 300 mg
IV vedolizumab 300 mg during maintenance
|
Placebo (Maintenance Period)
IV placebo during induction, SC placebo during maintenance
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence of Anti-drug Antibodies (Induction)
Week 10 · Number of subjects with any ADA results
|
66 Participants
|
62 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Anti-drug Antibodies (Induction)
Week 10 · Positive ADA
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Anti-drug Antibodies (Induction)
Week 10 · nAbs
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Anti-drug Antibodies (Induction)
Week 10 · no results
|
9 Participants
|
11 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Anti-drug Antibodies (Induction)
Baseline (Week 0) · Number of subjects with any ADA results
|
71 Participants
|
70 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Anti-drug Antibodies (Induction)
Baseline (Week 0) · Positive ADA
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Anti-drug Antibodies (Induction)
Baseline (Week 0) · nAbs
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Anti-drug Antibodies (Induction)
Baseline (Week 0) · no results
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Anti-drug Antibodies (Induction)
Week 6 · Number of subjects with any ADA results
|
68 Participants
|
61 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Anti-drug Antibodies (Induction)
Week 6 · Positive ADA
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Anti-drug Antibodies (Induction)
Week 6 · nAbs
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Anti-drug Antibodies (Induction)
Week 6 · no results
|
7 Participants
|
12 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through week 68: Induction: AE with onset on or after first IV dose up to SC dose, or early term trt date + 18 wks after last dose. Maintenance: AE with onset on or after first SC dose up to and including 18 weeks after date of last SC dose.Population: Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
Number and percentage of patients with reported adverse events.
Outcome measures
| Measure |
Brazikumab 720 mg
n=73 Participants
IV brazikumab 720 mg during induction period
|
Brazikumab 1440 mg
n=73 Participants
IV brazikumab 1440 mg during induction period
|
Brazikumab 2100 mg
n=10 Participants
IV brazikumab 2100 mg during induction period
|
Vedolizumab
n=10 Participants
IV vedolizumab 300 mg during induction period
|
Placebo
n=71 Participants
IV placebo during induction period
|
Brazikumab 720 mg/120 mg (Maintenance Period)
n=31 Participants
IV brazikumab 720 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 720 mg/240 mg (Maintenance Period)
n=28 Participants
IV brazikumab 720 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 120 mg (Maintenance Period)
n=31 Participants
IV brazikuamb 1440 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 240 mg (Maintenance Period)
n=31 Participants
IV brazikumab 1440 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 2100 mg/Brazikumab 120 (Maintenance Period)
n=6 Participants
IV brazikumab 2100 mg during induction period, SC brazikuamb 120 during maintenance
|
Braziumab 2100 mg/Brazikumab 240 mg (Maintenance Period)
n=4 Participants
IV brazikumab 2100 during induction period SC brazikumab 240 mg during maintenance
|
Vedoliumab 300 mg
n=9 Participants
IV vedolizumab 300 mg during maintenance
|
Placebo (Maintenance Period)
n=58 Participants
IV placebo during induction, SC placebo during maintenance
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Adverse Events
|
31 Participants
|
33 Participants
|
7 Participants
|
5 Participants
|
24 Participants
|
16 Participants
|
5 Participants
|
16 Participants
|
15 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: through week 68Population: Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
Percentage of patients with potentially clinically significant changes in hematology, clinical chemistry, urinalysis.
Outcome measures
| Measure |
Brazikumab 720 mg
n=73 Participants
IV brazikumab 720 mg during induction period
|
Brazikumab 1440 mg
n=73 Participants
IV brazikumab 1440 mg during induction period
|
Brazikumab 2100 mg
n=10 Participants
IV brazikumab 2100 mg during induction period
|
Vedolizumab
n=10 Participants
IV vedolizumab 300 mg during induction period
|
Placebo
n=71 Participants
IV placebo during induction period
|
Brazikumab 720 mg/120 mg (Maintenance Period)
n=31 Participants
IV brazikumab 720 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 720 mg/240 mg (Maintenance Period)
n=28 Participants
IV brazikumab 720 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 120 mg (Maintenance Period)
n=31 Participants
IV brazikuamb 1440 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 240 mg (Maintenance Period)
n=31 Participants
IV brazikumab 1440 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 2100 mg/Brazikumab 120 (Maintenance Period)
n=6 Participants
IV brazikumab 2100 mg during induction period, SC brazikuamb 120 during maintenance
|
Braziumab 2100 mg/Brazikumab 240 mg (Maintenance Period)
n=4 Participants
IV brazikumab 2100 during induction period SC brazikumab 240 mg during maintenance
|
Vedoliumab 300 mg
n=9 Participants
IV vedolizumab 300 mg during maintenance
|
Placebo (Maintenance Period)
n=58 Participants
IV placebo during induction, SC placebo during maintenance
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Laboratory Values
Creatinine · Normal
|
72 Participants
|
73 Participants
|
10 Participants
|
10 Participants
|
68 Participants
|
28 Participants
|
24 Participants
|
26 Participants
|
29 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
43 Participants
|
|
Laboratory Values
Glucose (mmol/L) · High
|
9 Participants
|
13 Participants
|
5 Participants
|
1 Participants
|
12 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
6 Participants
|
|
Laboratory Values
Glucose (mmol/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Laboratory Values
Glucose (mmol/L) · Normal
|
63 Participants
|
60 Participants
|
5 Participants
|
9 Participants
|
53 Participants
|
25 Participants
|
24 Participants
|
21 Participants
|
26 Participants
|
4 Participants
|
1 Participants
|
7 Participants
|
36 Participants
|
|
Laboratory Values
Magnesium · High
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Specific Gravity (RATIO) · High
|
13 Participants
|
9 Participants
|
1 Participants
|
1 Participants
|
15 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
14 Participants
|
|
Laboratory Values
Urine Specific Gravity (RATIO) · Low
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Specific Gravity (RATIO) · Normal
|
58 Participants
|
62 Participants
|
9 Participants
|
7 Participants
|
52 Participants
|
22 Participants
|
21 Participants
|
22 Participants
|
24 Participants
|
5 Participants
|
2 Participants
|
7 Participants
|
26 Participants
|
|
Laboratory Values
Urine Urobilinogen (Arbitrary U) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Magnesium · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Urobilinogen (Arbitrary U) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Urobilinogen (Arbitrary U) · Normal
|
72 Participants
|
72 Participants
|
10 Participants
|
9 Participants
|
67 Participants
|
27 Participants
|
24 Participants
|
24 Participants
|
27 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
40 Participants
|
|
Laboratory Values
Magnesium · Normal
|
70 Participants
|
72 Participants
|
10 Participants
|
10 Participants
|
67 Participants
|
28 Participants
|
23 Participants
|
26 Participants
|
29 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
43 Participants
|
|
Laboratory Values
Potassium · High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Potassium · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Potassium · Normal
|
72 Participants
|
73 Participants
|
10 Participants
|
10 Participants
|
67 Participants
|
28 Participants
|
24 Participants
|
25 Participants
|
29 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
43 Participants
|
|
Laboratory Values
Chloride (mmol/L) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Chloride (mmol/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Chloride (mmol/L) · Normal
|
72 Participants
|
73 Participants
|
10 Participants
|
10 Participants
|
68 Participants
|
28 Participants
|
24 Participants
|
26 Participants
|
29 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
43 Participants
|
|
Laboratory Values
Creatinine · High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Creatinine · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Protein (g/L) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Protein (g/L) · Low
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Laboratory Values
Protein (g/L) · Normal
|
72 Participants
|
72 Participants
|
10 Participants
|
10 Participants
|
68 Participants
|
27 Participants
|
24 Participants
|
26 Participants
|
29 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
42 Participants
|
|
Laboratory Values
Sodium · High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Sodium · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Sodium · Normal
|
72 Participants
|
73 Participants
|
10 Participants
|
10 Participants
|
68 Participants
|
28 Participants
|
24 Participants
|
26 Participants
|
29 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
43 Participants
|
|
Laboratory Values
Urate · High
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urate · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urate · Normal
|
71 Participants
|
72 Participants
|
10 Participants
|
10 Participants
|
68 Participants
|
28 Participants
|
24 Participants
|
24 Participants
|
29 Participants
|
6 Participants
|
3 Participants
|
7 Participants
|
43 Participants
|
|
Laboratory Values
Urea Nitrogen (mmol/L) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urea Nitrogen (mmol/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urea Nitrogen (mmol/L) · Normal
|
72 Participants
|
73 Participants
|
10 Participants
|
10 Participants
|
68 Participants
|
28 Participants
|
24 Participants
|
26 Participants
|
29 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
43 Participants
|
|
Laboratory Values
Basophils/Leukocytes (%) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Basophils/Leukocytes (%) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Basophils/Leukocytes (%) · Normal
|
72 Participants
|
73 Participants
|
10 Participants
|
9 Participants
|
68 Participants
|
26 Participants
|
24 Participants
|
24 Participants
|
28 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
42 Participants
|
|
Laboratory Values
Eosinophils/Leukocytes (%) · High
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Eosinophils/Leukocytes (%) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Eosinophils/Leukocytes (%) · Normal
|
71 Participants
|
72 Participants
|
9 Participants
|
9 Participants
|
65 Participants
|
26 Participants
|
24 Participants
|
24 Participants
|
28 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
42 Participants
|
|
Laboratory Values
Hematocrit (RATIO) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Direct Bilirubin (Arbitrary U) · Normal
|
72 Participants
|
72 Participants
|
10 Participants
|
9 Participants
|
67 Participants
|
27 Participants
|
24 Participants
|
24 Participants
|
27 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
40 Participants
|
|
Laboratory Values
Alanine Aminotransferase (ukat/L) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Alanine Aminotransferase (ukat/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Alanine Aminotransferase (ukat/L) · Normal
|
72 Participants
|
73 Participants
|
10 Participants
|
9 Participants
|
68 Participants
|
28 Participants
|
24 Participants
|
26 Participants
|
29 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
43 Participants
|
|
Laboratory Values
Albumin (g/L) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Albumin (g/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Albumin (g/L) · Normal
|
72 Participants
|
73 Participants
|
10 Participants
|
10 Participants
|
68 Participants
|
28 Participants
|
24 Participants
|
26 Participants
|
29 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
43 Participants
|
|
Laboratory Values
Alkaline Phosphatase (ukat/L) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Alkaline Phosphatase (ukat/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Alkaline Phosphatase (ukat/L) · Normal
|
72 Participants
|
73 Participants
|
10 Participants
|
10 Participants
|
68 Participants
|
28 Participants
|
24 Participants
|
26 Participants
|
29 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
43 Participants
|
|
Laboratory Values
Aspartate Aminotransferase (ukat/L) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Aspartate Aminotransferase (ukat/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Aspartate Aminotransferase (ukat/L) · Normal
|
72 Participants
|
73 Participants
|
10 Participants
|
10 Participants
|
68 Participants
|
28 Participants
|
24 Participants
|
26 Participants
|
29 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
43 Participants
|
|
Laboratory Values
Bilirubin (umol/L) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Bilirubin (umol/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Bilirubin (umol/L) · Normal
|
72 Participants
|
73 Participants
|
10 Participants
|
10 Participants
|
67 Participants
|
28 Participants
|
24 Participants
|
25 Participants
|
29 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
43 Participants
|
|
Laboratory Values
Calcium (mmol/L) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Calcium (mmol/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Calcium (mmol/L) · Normal
|
72 Participants
|
73 Participants
|
10 Participants
|
10 Participants
|
68 Participants
|
28 Participants
|
24 Participants
|
26 Participants
|
29 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
43 Participants
|
|
Laboratory Values
Hematocrit (RATIO) · Low
|
7 Participants
|
8 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Laboratory Values
Hematocrit (RATIO) · Normal
|
65 Participants
|
65 Participants
|
10 Participants
|
8 Participants
|
62 Participants
|
26 Participants
|
22 Participants
|
22 Participants
|
26 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
38 Participants
|
|
Laboratory Values
Hemoglobin (g/L) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Hemoglobin (g/L) · Low
|
12 Participants
|
16 Participants
|
2 Participants
|
1 Participants
|
15 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
8 Participants
|
|
Laboratory Values
Hemoglobin (g/L) · Normal
|
60 Participants
|
57 Participants
|
8 Participants
|
8 Participants
|
53 Participants
|
25 Participants
|
19 Participants
|
21 Participants
|
24 Participants
|
5 Participants
|
2 Participants
|
7 Participants
|
34 Participants
|
|
Laboratory Values
Leukocytes (10^9/L) · High
|
6 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Laboratory Values
Leukocytes (10^9/L) · Low
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Laboratory Values
Leukocytes (10^9/L) · Normal
|
65 Participants
|
70 Participants
|
9 Participants
|
9 Participants
|
65 Participants
|
26 Participants
|
24 Participants
|
24 Participants
|
28 Participants
|
6 Participants
|
3 Participants
|
7 Participants
|
39 Participants
|
|
Laboratory Values
Lymphocytes/Leukocytes (%) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Lymphocytes/Leukocytes (%) · Low
|
6 Participants
|
7 Participants
|
0 Participants
|
1 Participants
|
12 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
|
Laboratory Values
Lymphocytes/Leukocytes (%) · Normal
|
66 Participants
|
66 Participants
|
10 Participants
|
8 Participants
|
56 Participants
|
25 Participants
|
22 Participants
|
23 Participants
|
27 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
37 Participants
|
|
Laboratory Values
Neutrophils/Leukocytes (%) · Normal
|
71 Participants
|
73 Participants
|
10 Participants
|
9 Participants
|
62 Participants
|
26 Participants
|
24 Participants
|
24 Participants
|
27 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
42 Participants
|
|
Laboratory Values
Platelets (10^9/L) · High
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Platelets (10^9/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Glucose (Arbitrary U) · High
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Laboratory Values
Urine Glucose (Arbitrary U) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Monocytes/Leukocytes (%) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Monocytes/Leukocytes (%) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Monocytes/Leukocytes (%) · Normal
|
72 Participants
|
73 Participants
|
10 Participants
|
9 Participants
|
68 Participants
|
26 Participants
|
24 Participants
|
24 Participants
|
28 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
42 Participants
|
|
Laboratory Values
Neutrophils (10^9/L) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Neutrophils (10^9/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Neutrophils (10^9/L) · Normal
|
72 Participants
|
73 Participants
|
10 Participants
|
9 Participants
|
67 Participants
|
26 Participants
|
24 Participants
|
24 Participants
|
28 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
42 Participants
|
|
Laboratory Values
Neutrophils/Leukocytes (%) · High
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Neutrophils/Leukocytes (%) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Protein (Arbitrary U) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Protein (Arbitrary U) · Normal
|
72 Participants
|
70 Participants
|
10 Participants
|
9 Participants
|
63 Participants
|
27 Participants
|
24 Participants
|
24 Participants
|
27 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
38 Participants
|
|
Laboratory Values
Urine Glucose (Arbitrary U) · Normal
|
69 Participants
|
71 Participants
|
9 Participants
|
9 Participants
|
63 Participants
|
27 Participants
|
23 Participants
|
24 Participants
|
27 Participants
|
5 Participants
|
3 Participants
|
7 Participants
|
39 Participants
|
|
Laboratory Values
Urine Ketone Bodies (Arbitrary U) · High
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Ketone Bodies (Arbitrary U) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Ketone Bodies (Arbitrary U) · Normal
|
71 Participants
|
70 Participants
|
10 Participants
|
9 Participants
|
66 Participants
|
27 Participants
|
23 Participants
|
23 Participants
|
27 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
40 Participants
|
|
Laboratory Values
Urine Leukocyte Esterase (Arbitrary U) · High
|
9 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
8 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Laboratory Values
Urine Leukocyte Esterase (Arbitrary U) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Leukocyte Esterase (Arbitrary U) · Normal
|
63 Participants
|
69 Participants
|
9 Participants
|
7 Participants
|
59 Participants
|
27 Participants
|
23 Participants
|
23 Participants
|
24 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
36 Participants
|
|
Laboratory Values
Urine Nitrite (Arbitrary U) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Laboratory Values
Urine Nitrite (Arbitrary U) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Nitrite (Arbitrary U) · Normal
|
72 Participants
|
72 Participants
|
10 Participants
|
9 Participants
|
67 Participants
|
27 Participants
|
24 Participants
|
24 Participants
|
27 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
39 Participants
|
|
Laboratory Values
Urine Protein (Arbitrary U) · High
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Laboratory Values
Platelets (10^9/L) · Normal
|
71 Participants
|
73 Participants
|
10 Participants
|
9 Participants
|
62 Participants
|
26 Participants
|
24 Participants
|
24 Participants
|
27 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
42 Participants
|
|
Laboratory Values
Urine Direct Bilirubin (Arbitrary U) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Direct Bilirubin (Arbitrary U) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: through week 68Population: Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
Percentage of patients with potentially clinically significant changes in systolic and diastolic blood pressure, and pulse rate.
Outcome measures
| Measure |
Brazikumab 720 mg
n=73 Participants
IV brazikumab 720 mg during induction period
|
Brazikumab 1440 mg
n=73 Participants
IV brazikumab 1440 mg during induction period
|
Brazikumab 2100 mg
n=10 Participants
IV brazikumab 2100 mg during induction period
|
Vedolizumab
n=10 Participants
IV vedolizumab 300 mg during induction period
|
Placebo
n=71 Participants
IV placebo during induction period
|
Brazikumab 720 mg/120 mg (Maintenance Period)
n=31 Participants
IV brazikumab 720 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 720 mg/240 mg (Maintenance Period)
n=28 Participants
IV brazikumab 720 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 120 mg (Maintenance Period)
n=31 Participants
IV brazikuamb 1440 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 240 mg (Maintenance Period)
n=31 Participants
IV brazikumab 1440 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 2100 mg/Brazikumab 120 (Maintenance Period)
n=6 Participants
IV brazikumab 2100 mg during induction period, SC brazikuamb 120 during maintenance
|
Braziumab 2100 mg/Brazikumab 240 mg (Maintenance Period)
n=4 Participants
IV brazikumab 2100 during induction period SC brazikumab 240 mg during maintenance
|
Vedoliumab 300 mg
n=9 Participants
IV vedolizumab 300 mg during maintenance
|
Placebo (Maintenance Period)
n=58 Participants
IV placebo during induction, SC placebo during maintenance
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Vital Signs
Sitting systolic blood pressure (mmHg) · High
|
5 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Vital Signs
Sitting systolic blood pressure (mmHg) · Low
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Vital Signs
Sitting systolic blood pressure (mmHg) · Normal
|
68 Participants
|
65 Participants
|
7 Participants
|
9 Participants
|
66 Participants
|
26 Participants
|
21 Participants
|
29 Participants
|
29 Participants
|
5 Participants
|
2 Participants
|
9 Participants
|
43 Participants
|
|
Vital Signs
Sitting diastolic blood pressure (mmHg) · High
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Vital Signs
Sitting diastolic blood pressure (mmHg) · Low
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Vital Signs
Sitting diastolic blood pressure (mmHg) · Normal
|
69 Participants
|
69 Participants
|
9 Participants
|
10 Participants
|
65 Participants
|
24 Participants
|
20 Participants
|
25 Participants
|
27 Participants
|
4 Participants
|
2 Participants
|
9 Participants
|
42 Participants
|
|
Vital Signs
Sitting pulse rate (bpm) · Low
|
7 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Vital Signs
Sitting pulse rate (bpm) · Normal
|
63 Participants
|
61 Participants
|
10 Participants
|
10 Participants
|
63 Participants
|
22 Participants
|
17 Participants
|
26 Participants
|
27 Participants
|
5 Participants
|
3 Participants
|
8 Participants
|
38 Participants
|
|
Vital Signs
Weight (kg) · High
|
11 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
10 Participants
|
7 Participants
|
13 Participants
|
12 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
12 Participants
|
|
Vital Signs
Sitting pulse rate (bpm) · High
|
3 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
|
Vital Signs
Weight (kg) · Low
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Vital Signs
Weight (kg) · Normal
|
59 Participants
|
64 Participants
|
10 Participants
|
10 Participants
|
63 Participants
|
18 Participants
|
16 Participants
|
17 Participants
|
18 Participants
|
1 Participants
|
2 Participants
|
8 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: through week 68Population: Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
Percentage of patients with potentially clinically significant changes in 12-lead ECG recordings
Outcome measures
| Measure |
Brazikumab 720 mg
n=73 Participants
IV brazikumab 720 mg during induction period
|
Brazikumab 1440 mg
n=73 Participants
IV brazikumab 1440 mg during induction period
|
Brazikumab 2100 mg
n=10 Participants
IV brazikumab 2100 mg during induction period
|
Vedolizumab
n=10 Participants
IV vedolizumab 300 mg during induction period
|
Placebo
n=71 Participants
IV placebo during induction period
|
Brazikumab 720 mg/120 mg (Maintenance Period)
n=31 Participants
IV brazikumab 720 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 720 mg/240 mg (Maintenance Period)
n=28 Participants
IV brazikumab 720 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 120 mg (Maintenance Period)
n=31 Participants
IV brazikuamb 1440 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 240 mg (Maintenance Period)
n=31 Participants
IV brazikumab 1440 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 2100 mg/Brazikumab 120 (Maintenance Period)
n=6 Participants
IV brazikumab 2100 mg during induction period, SC brazikuamb 120 during maintenance
|
Braziumab 2100 mg/Brazikumab 240 mg (Maintenance Period)
n=4 Participants
IV brazikumab 2100 during induction period SC brazikumab 240 mg during maintenance
|
Vedoliumab 300 mg
n=9 Participants
IV vedolizumab 300 mg during maintenance
|
Placebo (Maintenance Period)
n=58 Participants
IV placebo during induction, SC placebo during maintenance
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Abnormal ECG Results Through Week 68
|
11 Participants
|
9 Participants
|
1 Participants
|
2 Participants
|
8 Participants
|
7 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 30 through week 68Population: The PK population includes all participants who receive at least 1 dose of study intervention and have at least 1 PK sample containing detectable brazikumab concentrations.
Pharmacokinetics: concentration of brazikumab in serum
Outcome measures
| Measure |
Brazikumab 720 mg
n=31 Participants
IV brazikumab 720 mg during induction period
|
Brazikumab 1440 mg
n=28 Participants
IV brazikumab 1440 mg during induction period
|
Brazikumab 2100 mg
n=31 Participants
IV brazikumab 2100 mg during induction period
|
Vedolizumab
n=31 Participants
IV vedolizumab 300 mg during induction period
|
Placebo
n=6 Participants
IV placebo during induction period
|
Brazikumab 720 mg/120 mg (Maintenance Period)
n=4 Participants
IV brazikumab 720 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 720 mg/240 mg (Maintenance Period)
IV brazikumab 720 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 120 mg (Maintenance Period)
IV brazikuamb 1440 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 1440 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 2100 mg/Brazikumab 120 (Maintenance Period)
IV brazikumab 2100 mg during induction period, SC brazikuamb 120 during maintenance
|
Braziumab 2100 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 2100 during induction period SC brazikumab 240 mg during maintenance
|
Vedoliumab 300 mg
IV vedolizumab 300 mg during maintenance
|
Placebo (Maintenance Period)
IV placebo during induction, SC placebo during maintenance
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum Concentrations of Brazikumab (Maintenance)
Week 54
|
719123.744 ng/mL
Standard Deviation 15421.690
|
29794.373 ng/mL
Standard Deviation 5128.980
|
11805.250 ng/mL
Standard Deviation 4567.285
|
22789.048 ng/mL
Standard Deviation 13867.140
|
10950.612 ng/mL
Standard Deviation 1791.104
|
34904.155 ng/mL
Standard Deviation 3140.707
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of Brazikumab (Maintenance)
Week 30
|
12822.658 ng/mL
Standard Deviation 6088.023
|
28066.063 ng/mL
Standard Deviation 12474.775
|
17367.065 ng/mL
Standard Deviation 7011.106
|
32548.972 ng/mL
Standard Deviation 20388.755
|
19278.823 ng/mL
Standard Deviation 13841.613
|
23812.200 ng/mL
Standard Deviation 15508.765
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 30 through week 68Population: The data is reported for the PK population including all participants who receive at least 1 dose of study intervention and have at least 1 PK sample containing detectable brazikumab concentrations.
Immunogenicity: incidence of brazikumab anti-drug antibodies in serum
Outcome measures
| Measure |
Brazikumab 720 mg
n=31 Participants
IV brazikumab 720 mg during induction period
|
Brazikumab 1440 mg
n=28 Participants
IV brazikumab 1440 mg during induction period
|
Brazikumab 2100 mg
n=31 Participants
IV brazikumab 2100 mg during induction period
|
Vedolizumab
n=31 Participants
IV vedolizumab 300 mg during induction period
|
Placebo
n=6 Participants
IV placebo during induction period
|
Brazikumab 720 mg/120 mg (Maintenance Period)
n=4 Participants
IV brazikumab 720 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 720 mg/240 mg (Maintenance Period)
IV brazikumab 720 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 120 mg (Maintenance Period)
IV brazikuamb 1440 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 1440 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 2100 mg/Brazikumab 120 (Maintenance Period)
IV brazikumab 2100 mg during induction period, SC brazikuamb 120 during maintenance
|
Braziumab 2100 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 2100 during induction period SC brazikumab 240 mg during maintenance
|
Vedoliumab 300 mg
IV vedolizumab 300 mg during maintenance
|
Placebo (Maintenance Period)
IV placebo during induction, SC placebo during maintenance
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence of Anti-drug Antibodies (Maintenance)
Week 30 · no results
|
13 Participants
|
13 Participants
|
17 Participants
|
11 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Anti-drug Antibodies (Maintenance)
Week 54 · Number of subjects with any ADA results
|
6 Participants
|
6 Participants
|
8 Participants
|
8 Participants
|
5 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Anti-drug Antibodies (Maintenance)
Week 54 · nAbs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Anti-drug Antibodies (Maintenance)
Week 54 · no results
|
23 Participants
|
22 Participants
|
23 Participants
|
23 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Anti-drug Antibodies (Maintenance)
Week 30 · Number of subjects with any ADA results
|
18 Participants
|
15 Participants
|
14 Participants
|
20 Participants
|
6 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Anti-drug Antibodies (Maintenance)
Week 30 · Positive ADA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Anti-drug Antibodies (Maintenance)
Week 30 · nAbs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Anti-drug Antibodies (Maintenance)
Week 54 · Positive ADA
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: through Week 10Population: The efficacy analysis set includes subjects who had completed the induction period at time of study termination, or who would have had the opportunity to complete the induction period at the time of the termination if not prematurely discontinuing IP. The reason for excluding subjects was to avoid bias in the analysis.
mMS total score at baseline and Week 10
Outcome measures
| Measure |
Brazikumab 720 mg
n=65 Participants
IV brazikumab 720 mg during induction period
|
Brazikumab 1440 mg
n=65 Participants
IV brazikumab 1440 mg during induction period
|
Brazikumab 2100 mg
n=10 Participants
IV brazikumab 2100 mg during induction period
|
Vedolizumab
n=10 Participants
IV vedolizumab 300 mg during induction period
|
Placebo
n=65 Participants
IV placebo during induction period
|
Brazikumab 720 mg/120 mg (Maintenance Period)
IV brazikumab 720 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 720 mg/240 mg (Maintenance Period)
IV brazikumab 720 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 120 mg (Maintenance Period)
IV brazikuamb 1440 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 1440 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 2100 mg/Brazikumab 120 (Maintenance Period)
IV brazikumab 2100 mg during induction period, SC brazikuamb 120 during maintenance
|
Braziumab 2100 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 2100 during induction period SC brazikumab 240 mg during maintenance
|
Vedoliumab 300 mg
IV vedolizumab 300 mg during maintenance
|
Placebo (Maintenance Period)
IV placebo during induction, SC placebo during maintenance
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
mMS Total Score (Induction)
Baseline
|
6.5 score
Standard Deviation 1.14
|
6.4 score
Standard Deviation 1.29
|
5.8 score
Standard Deviation 1.75
|
6.9 score
Standard Deviation 1.45
|
6.4 score
Standard Deviation 1.10
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Total Score (Induction)
Week 10
|
3.3 score
Standard Deviation 2.38
|
2.8 score
Standard Deviation 1.97
|
2.4 score
Standard Deviation 1.92
|
3.5 score
Standard Deviation 1.51
|
4.6 score
Standard Deviation 2.09
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: through Week 10Population: The efficacy analysis set includes subjects who had completed the induction period at time of study termination, or who would have had the opportunity to complete the induction period at the time of the termination if not prematurely discontinuing IP. The reason for excluding subjects was to avoid bias in the analysis.
Number of participants in each score category for Endoscopy score
Outcome measures
| Measure |
Brazikumab 720 mg
n=65 Participants
IV brazikumab 720 mg during induction period
|
Brazikumab 1440 mg
n=65 Participants
IV brazikumab 1440 mg during induction period
|
Brazikumab 2100 mg
n=10 Participants
IV brazikumab 2100 mg during induction period
|
Vedolizumab
n=10 Participants
IV vedolizumab 300 mg during induction period
|
Placebo
n=65 Participants
IV placebo during induction period
|
Brazikumab 720 mg/120 mg (Maintenance Period)
IV brazikumab 720 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 720 mg/240 mg (Maintenance Period)
IV brazikumab 720 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 120 mg (Maintenance Period)
IV brazikuamb 1440 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 1440 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 2100 mg/Brazikumab 120 (Maintenance Period)
IV brazikumab 2100 mg during induction period, SC brazikuamb 120 during maintenance
|
Braziumab 2100 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 2100 during induction period SC brazikumab 240 mg during maintenance
|
Vedoliumab 300 mg
IV vedolizumab 300 mg during maintenance
|
Placebo (Maintenance Period)
IV placebo during induction, SC placebo during maintenance
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
mMS Component Score: Endoscopy (Induction)
Baseline · Endoscopy score 2
|
29 Participants
|
24 Participants
|
5 Participants
|
5 Participants
|
25 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Endoscopy (Induction)
Baseline · Endoscopy score 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Endoscopy (Induction)
Baseline · Endoscopy score 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Endoscopy (Induction)
Baseline · Endoscopy score 3
|
36 Participants
|
41 Participants
|
5 Participants
|
5 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Endoscopy (Induction)
Baseline · no data
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Endoscopy (Induction)
Week 10 · Endoscopy score 0
|
9 Participants
|
11 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Endoscopy (Induction)
Week 10 · Endoscopy score 1
|
12 Participants
|
13 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Endoscopy (Induction)
Week 10 · Endoscopy score 2
|
19 Participants
|
20 Participants
|
3 Participants
|
3 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Endoscopy (Induction)
Week 10 · Endoscopy score 3
|
17 Participants
|
15 Participants
|
1 Participants
|
3 Participants
|
30 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Endoscopy (Induction)
Week 10 · no data
|
8 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: through Week 10Population: The efficacy analysis set includes subjects who had completed the induction period at time of study termination, or who would have had the opportunity to complete the induction period at the time of the termination if not prematurely discontinuing IP. The reason for excluding subjects was to avoid bias in the analysis.
Number of participants in each score category for Stool frequency
Outcome measures
| Measure |
Brazikumab 720 mg
n=65 Participants
IV brazikumab 720 mg during induction period
|
Brazikumab 1440 mg
n=65 Participants
IV brazikumab 1440 mg during induction period
|
Brazikumab 2100 mg
n=10 Participants
IV brazikumab 2100 mg during induction period
|
Vedolizumab
n=10 Participants
IV vedolizumab 300 mg during induction period
|
Placebo
n=65 Participants
IV placebo during induction period
|
Brazikumab 720 mg/120 mg (Maintenance Period)
IV brazikumab 720 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 720 mg/240 mg (Maintenance Period)
IV brazikumab 720 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 120 mg (Maintenance Period)
IV brazikuamb 1440 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 1440 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 2100 mg/Brazikumab 120 (Maintenance Period)
IV brazikumab 2100 mg during induction period, SC brazikuamb 120 during maintenance
|
Braziumab 2100 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 2100 during induction period SC brazikumab 240 mg during maintenance
|
Vedoliumab 300 mg
IV vedolizumab 300 mg during maintenance
|
Placebo (Maintenance Period)
IV placebo during induction, SC placebo during maintenance
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
mMS Component Score: Stool Frequency (Induction)
Baseline · Stool frequency score 0
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Stool Frequency (Induction)
Baseline · Stool frequency score 1
|
11 Participants
|
17 Participants
|
1 Participants
|
1 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Stool Frequency (Induction)
Baseline · Stool frequency score 2
|
29 Participants
|
21 Participants
|
4 Participants
|
2 Participants
|
27 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Stool Frequency (Induction)
Baseline · Stool frequency score 3
|
24 Participants
|
25 Participants
|
2 Participants
|
6 Participants
|
24 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Stool Frequency (Induction)
Baseline · no data
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Stool Frequency (Induction)
Week 10 · Stool frequency score 0
|
27 Participants
|
27 Participants
|
4 Participants
|
2 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Stool Frequency (Induction)
Week 10 · Stool frequency score 1
|
12 Participants
|
18 Participants
|
3 Participants
|
3 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Stool Frequency (Induction)
Week 10 · Stool frequency score 2
|
10 Participants
|
8 Participants
|
0 Participants
|
2 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Stool Frequency (Induction)
Week 10 · Stool frequency score 3
|
9 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Stool Frequency (Induction)
Week 10 · no data
|
7 Participants
|
11 Participants
|
2 Participants
|
2 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: through Week 10Population: The efficacy analysis set includes subjects who had completed the induction period at time of study termination, or who would have had the opportunity to complete the induction period at the time of the termination if not prematurely discontinuing IP. The reason for excluding subjects was to avoid bias in the analysis.
Number of participants in each score category for Rectal bleeding
Outcome measures
| Measure |
Brazikumab 720 mg
n=65 Participants
IV brazikumab 720 mg during induction period
|
Brazikumab 1440 mg
n=65 Participants
IV brazikumab 1440 mg during induction period
|
Brazikumab 2100 mg
n=10 Participants
IV brazikumab 2100 mg during induction period
|
Vedolizumab
n=10 Participants
IV vedolizumab 300 mg during induction period
|
Placebo
n=65 Participants
IV placebo during induction period
|
Brazikumab 720 mg/120 mg (Maintenance Period)
IV brazikumab 720 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 720 mg/240 mg (Maintenance Period)
IV brazikumab 720 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 120 mg (Maintenance Period)
IV brazikuamb 1440 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 1440 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 2100 mg/Brazikumab 120 (Maintenance Period)
IV brazikumab 2100 mg during induction period, SC brazikuamb 120 during maintenance
|
Braziumab 2100 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 2100 during induction period SC brazikumab 240 mg during maintenance
|
Vedoliumab 300 mg
IV vedolizumab 300 mg during maintenance
|
Placebo (Maintenance Period)
IV placebo during induction, SC placebo during maintenance
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
mMS Component Score: Rectal Bleeding (Induction)
Baseline · Rectal bleeding score 2
|
46 Participants
|
37 Participants
|
4 Participants
|
4 Participants
|
35 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Rectal Bleeding (Induction)
Baseline · Rectal bleeding score 3
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Rectal Bleeding (Induction)
Week 10 · no data
|
7 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Rectal Bleeding (Induction)
Baseline · Rectal bleeding score 0
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Rectal Bleeding (Induction)
Baseline · Rectal bleeding score 1
|
17 Participants
|
25 Participants
|
3 Participants
|
2 Participants
|
26 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Rectal Bleeding (Induction)
Baseline · no data
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Rectal Bleeding (Induction)
Week 10 · Rectal bleeding score 0
|
41 Participants
|
48 Participants
|
6 Participants
|
4 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Rectal Bleeding (Induction)
Week 10 · Rectal bleeding score 1
|
8 Participants
|
9 Participants
|
2 Participants
|
4 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Rectal Bleeding (Induction)
Week 10 · Rectal bleeding score 2
|
8 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Rectal Bleeding (Induction)
Week 10 · Rectal bleeding score 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 54Population: The efficacy analysis set includes subjects who had completed the induction period at time of study termination, or who would have had the opportunity to complete the induction period at the time of the termination if not prematurely discontinuing IP. The reason for excluding subjects was to avoid bias in the analysis.
mMS total score at baseline and Week 54
Outcome measures
| Measure |
Brazikumab 720 mg
n=31 Participants
IV brazikumab 720 mg during induction period
|
Brazikumab 1440 mg
n=28 Participants
IV brazikumab 1440 mg during induction period
|
Brazikumab 2100 mg
n=31 Participants
IV brazikumab 2100 mg during induction period
|
Vedolizumab
n=31 Participants
IV vedolizumab 300 mg during induction period
|
Placebo
n=6 Participants
IV placebo during induction period
|
Brazikumab 720 mg/120 mg (Maintenance Period)
n=4 Participants
IV brazikumab 720 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 720 mg/240 mg (Maintenance Period)
n=10 Participants
IV brazikumab 720 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 120 mg (Maintenance Period)
n=65 Participants
IV brazikuamb 1440 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 1440 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 2100 mg/Brazikumab 120 (Maintenance Period)
IV brazikumab 2100 mg during induction period, SC brazikuamb 120 during maintenance
|
Braziumab 2100 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 2100 during induction period SC brazikumab 240 mg during maintenance
|
Vedoliumab 300 mg
IV vedolizumab 300 mg during maintenance
|
Placebo (Maintenance Period)
IV placebo during induction, SC placebo during maintenance
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Total mMS (Maintenance)
Total score at Baseline
|
6.8 points
Standard Deviation 0.91
|
6.1 points
Standard Deviation 1.35
|
6.56 points
Standard Deviation 1.28
|
6.0 points
Standard Deviation 1.28
|
5.5 points
Standard Deviation 1.91
|
6.0 points
Standard Deviation 1.83
|
6.9 points
Standard Deviation 1.45
|
6.4 points
Standard Deviation 1.10
|
—
|
—
|
—
|
—
|
—
|
|
Total mMS (Maintenance)
Total score at Week 54
|
1.6 points
Standard Deviation 1.27
|
1.3 points
Standard Deviation 0.76
|
3.0 points
Standard Deviation 2.83
|
1.4 points
Standard Deviation 1.13
|
2.5 points
Standard Deviation 0.71
|
1.0 points
Standard Deviation 0
|
2.7 points
Standard Deviation 1.53
|
3.0 points
Standard Deviation 1.79
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: through Week 54Population: The efficacy analysis set includes subjects who had completed the induction period at time of study termination, or who would have had the opportunity to complete the induction period at the time of the termination if not prematurely discontinuing IP. The reason for excluding subjects was to avoid bias in the analysis.
Number of participants in each score category for Endoscopy score
Outcome measures
| Measure |
Brazikumab 720 mg
n=31 Participants
IV brazikumab 720 mg during induction period
|
Brazikumab 1440 mg
n=28 Participants
IV brazikumab 1440 mg during induction period
|
Brazikumab 2100 mg
n=31 Participants
IV brazikumab 2100 mg during induction period
|
Vedolizumab
n=31 Participants
IV vedolizumab 300 mg during induction period
|
Placebo
n=6 Participants
IV placebo during induction period
|
Brazikumab 720 mg/120 mg (Maintenance Period)
n=4 Participants
IV brazikumab 720 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 720 mg/240 mg (Maintenance Period)
n=10 Participants
IV brazikumab 720 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 120 mg (Maintenance Period)
n=65 Participants
IV brazikuamb 1440 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 1440 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 2100 mg/Brazikumab 120 (Maintenance Period)
IV brazikumab 2100 mg during induction period, SC brazikuamb 120 during maintenance
|
Braziumab 2100 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 2100 during induction period SC brazikumab 240 mg during maintenance
|
Vedoliumab 300 mg
IV vedolizumab 300 mg during maintenance
|
Placebo (Maintenance Period)
IV placebo during induction, SC placebo during maintenance
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
mMS Component Score: Endoscopy (Maintenance)
Baseline · Endoscopy score 2
|
12 Participants
|
15 Participants
|
9 Participants
|
14 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
25 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Endoscopy (Maintenance)
Baseline · Endoscopy score 3
|
19 Participants
|
13 Participants
|
22 Participants
|
17 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Endoscopy (Maintenance)
Baseline · no data
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Endoscopy (Maintenance)
Week 54 · Endoscopy score 0
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Endoscopy (Maintenance)
Week 54 · Endoscopy score 2
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Endoscopy (Maintenance)
Week 54 · Endoscopy score 3
|
1 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Endoscopy (Maintenance)
Week 54 · no data
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Endoscopy (Maintenance)
Baseline · Endoscopy score 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Endoscopy (Maintenance)
Baseline · Endoscopy score 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Endoscopy (Maintenance)
Week 54 · Endoscopy score 1
|
2 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: through Week 54Population: The efficacy analysis set includes subjects who had completed the induction period at time of study termination, or who would have had the opportunity to complete the induction period at the time of the termination if not prematurely discontinuing IP. The reason for excluding subjects was to avoid bias in the analysis.
Number of participants in each score category for Stool frequency score
Outcome measures
| Measure |
Brazikumab 720 mg
n=31 Participants
IV brazikumab 720 mg during induction period
|
Brazikumab 1440 mg
n=28 Participants
IV brazikumab 1440 mg during induction period
|
Brazikumab 2100 mg
n=31 Participants
IV brazikumab 2100 mg during induction period
|
Vedolizumab
n=31 Participants
IV vedolizumab 300 mg during induction period
|
Placebo
n=6 Participants
IV placebo during induction period
|
Brazikumab 720 mg/120 mg (Maintenance Period)
n=4 Participants
IV brazikumab 720 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 720 mg/240 mg (Maintenance Period)
n=10 Participants
IV brazikumab 720 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 120 mg (Maintenance Period)
n=65 Participants
IV brazikuamb 1440 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 1440 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 2100 mg/Brazikumab 120 (Maintenance Period)
IV brazikumab 2100 mg during induction period, SC brazikuamb 120 during maintenance
|
Braziumab 2100 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 2100 during induction period SC brazikumab 240 mg during maintenance
|
Vedoliumab 300 mg
IV vedolizumab 300 mg during maintenance
|
Placebo (Maintenance Period)
IV placebo during induction, SC placebo during maintenance
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
mMS Component Score: Stool Frequency (Maintenance)
Baseline · Stool frequency score 0
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Stool Frequency (Maintenance)
Baseline · Stool frequency score 1
|
1 Participants
|
10 Participants
|
6 Participants
|
11 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Stool Frequency (Maintenance)
Baseline · Stool frequency score 2
|
17 Participants
|
9 Participants
|
9 Participants
|
11 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
27 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Stool Frequency (Maintenance)
Baseline · Stool frequency score 3
|
13 Participants
|
8 Participants
|
15 Participants
|
8 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
24 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Stool Frequency (Maintenance)
Baseline · no data
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Stool Frequency (Maintenance)
Week 54 · Stool frequency score 0
|
6 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Stool Frequency (Maintenance)
Week 54 · Stool frequency score 1
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Stool Frequency (Maintenance)
Week 54 · Stool frequency score 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Stool Frequency (Maintenance)
Week 54 · Stool frequency score 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Stool Frequency (Maintenance)
Week 54 · no data
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: through Week 54Population: The efficacy analysis set includes subjects who had completed the induction period at time of study termination, or who would have had the opportunity to complete the induction period at the time of the termination if not prematurely discontinuing IP. The reason for excluding subjects was to avoid bias in the analysis.
Number of participants in each score category for Rectal bleeding score
Outcome measures
| Measure |
Brazikumab 720 mg
n=31 Participants
IV brazikumab 720 mg during induction period
|
Brazikumab 1440 mg
n=28 Participants
IV brazikumab 1440 mg during induction period
|
Brazikumab 2100 mg
n=31 Participants
IV brazikumab 2100 mg during induction period
|
Vedolizumab
n=31 Participants
IV vedolizumab 300 mg during induction period
|
Placebo
n=6 Participants
IV placebo during induction period
|
Brazikumab 720 mg/120 mg (Maintenance Period)
n=4 Participants
IV brazikumab 720 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 720 mg/240 mg (Maintenance Period)
n=10 Participants
IV brazikumab 720 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 120 mg (Maintenance Period)
n=65 Participants
IV brazikuamb 1440 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 1440 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 1440 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 2100 mg/Brazikumab 120 (Maintenance Period)
IV brazikumab 2100 mg during induction period, SC brazikuamb 120 during maintenance
|
Braziumab 2100 mg/Brazikumab 240 mg (Maintenance Period)
IV brazikumab 2100 during induction period SC brazikumab 240 mg during maintenance
|
Vedoliumab 300 mg
IV vedolizumab 300 mg during maintenance
|
Placebo (Maintenance Period)
IV placebo during induction, SC placebo during maintenance
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
mMS Component Score: Rectal Bleeding (Maintenance)
Week 54 · no data
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Rectal Bleeding (Maintenance)
Baseline · Rectal bleeding score 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Rectal Bleeding (Maintenance)
Baseline · Rectal bleeding score 1
|
7 Participants
|
7 Participants
|
11 Participants
|
13 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
26 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Rectal Bleeding (Maintenance)
Baseline · Rectal bleeding score 2
|
23 Participants
|
20 Participants
|
19 Participants
|
16 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
35 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Rectal Bleeding (Maintenance)
Baseline · Rectal bleeding score 3
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Rectal Bleeding (Maintenance)
Baseline · no data
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Rectal Bleeding (Maintenance)
Week 54 · Rectal bleeding score 0
|
6 Participants
|
7 Participants
|
5 Participants
|
7 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Rectal Bleeding (Maintenance)
Week 54 · Rectal bleeding score 1
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Rectal Bleeding (Maintenance)
Week 54 · Rectal bleeding score 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
mMS Component Score: Rectal Bleeding (Maintenance)
Week 54 · Rectal bleeding score 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: through week 68Population: Any new or aggravated clinically relevant abnormal medical finding occurring at a physical examination (PE) as compared with the Baseline assessment was considered as a treatment emergent adverse event and is reported in the Adverse Event section. No data related to the PE was captured and it was not captured for the adverse events if it was related to a PE. Since it was never collected it is not possible to report either any PE data or the AEs related to a PE separately.
Physical examination as safety assessment, to facilitate the evaluation of the safety objective (Adverse Events).
Outcome measures
Outcome data not reported
Adverse Events
Brazikumab 720 mg (Induction Period)
Serious events: 3 serious events
Other events: 31 other events
Deaths: 0 deaths
Brazikumab 1440 mg (Induction Period))
Serious events: 2 serious events
Other events: 33 other events
Deaths: 0 deaths
Brazikumab 2100 mg (Induction Period)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Vedolizumab 300 mg (Induction Period)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo (Induction Period)
Serious events: 4 serious events
Other events: 24 other events
Deaths: 0 deaths
Brazikumab 720 mg/120 mg (Maintenance Period)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Brazikumab 720 mg/240 mg (Maintenance Period)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Brazikumab 1440 mg/120 mg (Maintenance Period)
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Brazikumab 1440 mg/240 mg (Maintenance Period)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Brazikumab 2100mg/140 mg (Maintenance Period)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Brazikumab 2100 mg/240 mg (Maintenance Period)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Vedolizumab 300 mg (Maintenance Period)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo (Maintenance Period)
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brazikumab 720 mg (Induction Period)
n=73 participants at risk
IV brazikumab 720 mg during induction period
|
Brazikumab 1440 mg (Induction Period))
n=73 participants at risk
IV brazikumab 1440 mg during induction period
|
Brazikumab 2100 mg (Induction Period)
n=10 participants at risk
IV brazikumab 2100 mg during induction period
|
Vedolizumab 300 mg (Induction Period)
n=10 participants at risk
IV Vedolizumab 300 mg during Induction period
|
Placebo (Induction Period)
n=71 participants at risk
IV placebo during induction period
|
Brazikumab 720 mg/120 mg (Maintenance Period)
n=31 participants at risk
IV brazikumab 720 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 720 mg/240 mg (Maintenance Period)
n=28 participants at risk
IV brazikumab 720 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 1440 mg/120 mg (Maintenance Period)
n=31 participants at risk
IV brazikumab 1440 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 1440 mg/240 mg (Maintenance Period)
n=31 participants at risk
IV brazikumab 1440 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 2100mg/140 mg (Maintenance Period)
n=6 participants at risk
IV brazikumab 2100 mg during induction period, SC brazikumab 120 mg during maintenance
|
Brazikumab 2100 mg/240 mg (Maintenance Period)
n=4 participants at risk
IV brazikumab 2100 mg during induction, SC brazikumab 240 mg during maintenance
|
Vedolizumab 300 mg (Maintenance Period)
n=9 participants at risk
IV vedolizumab 300 mg during induction and maintenance
|
Placebo (Maintenance Period)
n=58 participants at risk
Placebo during maintenance period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
COVID-19
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Nervous system disorders
Cerebral artery stenosis
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
4.2%
3/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
Other adverse events
| Measure |
Brazikumab 720 mg (Induction Period)
n=73 participants at risk
IV brazikumab 720 mg during induction period
|
Brazikumab 1440 mg (Induction Period))
n=73 participants at risk
IV brazikumab 1440 mg during induction period
|
Brazikumab 2100 mg (Induction Period)
n=10 participants at risk
IV brazikumab 2100 mg during induction period
|
Vedolizumab 300 mg (Induction Period)
n=10 participants at risk
IV Vedolizumab 300 mg during Induction period
|
Placebo (Induction Period)
n=71 participants at risk
IV placebo during induction period
|
Brazikumab 720 mg/120 mg (Maintenance Period)
n=31 participants at risk
IV brazikumab 720 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 720 mg/240 mg (Maintenance Period)
n=28 participants at risk
IV brazikumab 720 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 1440 mg/120 mg (Maintenance Period)
n=31 participants at risk
IV brazikumab 1440 mg during induction, SC brazikumab 120 mg during maintenance
|
Brazikumab 1440 mg/240 mg (Maintenance Period)
n=31 participants at risk
IV brazikumab 1440 mg during induction, SC brazikumab 240 mg during maintenance
|
Brazikumab 2100mg/140 mg (Maintenance Period)
n=6 participants at risk
IV brazikumab 2100 mg during induction period, SC brazikumab 120 mg during maintenance
|
Brazikumab 2100 mg/240 mg (Maintenance Period)
n=4 participants at risk
IV brazikumab 2100 mg during induction, SC brazikumab 240 mg during maintenance
|
Vedolizumab 300 mg (Maintenance Period)
n=9 participants at risk
IV vedolizumab 300 mg during induction and maintenance
|
Placebo (Maintenance Period)
n=58 participants at risk
Placebo during maintenance period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Anal abscess
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
COVID-19
|
11.0%
8/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
2.7%
2/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
6.5%
2/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
6.5%
2/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
6.5%
2/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
25.0%
1/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
11.1%
1/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
5.2%
3/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Clostridium difficile infection
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
10.0%
1/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
11.1%
1/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Impetigo
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
4.1%
3/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
9.7%
3/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.6%
1/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.4%
2/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Oral herpes
|
2.7%
2/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Pharyngitis
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
10.0%
1/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
2.8%
2/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
11.1%
1/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Pustule
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Scarlet fever
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Sinusitis
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.7%
2/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
5.5%
4/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
4.2%
3/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
6.5%
2/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
34.5%
20/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
10.0%
1/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.7%
2/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Candida urethritis
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Ear infection
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Eye infection bacterial
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Furuncle
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
11.1%
1/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
7.1%
2/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Influenza
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
16.7%
1/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Laryngopharyngitis
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
25.0%
1/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.6%
1/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Skin infection
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
16.7%
1/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
6.5%
2/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Infections and infestations
Viral infection
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
4.2%
3/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.4%
2/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
10.0%
1/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
10.0%
1/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
16.7%
1/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Metabolism and nutrition disorders
Abnormal weight gain
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
25.0%
1/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
25.0%
1/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.4%
2/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.6%
1/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Nervous system disorders
Cerebral artery stenosis
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
10.0%
1/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
6.5%
2/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Nervous system disorders
Headache
|
2.7%
2/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
2.7%
2/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
10.0%
1/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
4.2%
3/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Nervous system disorders
Loss of consciouness
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
10.0%
1/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Nervous system disorders
Migraine
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
16.7%
1/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Nervous system disorders
Tension headache
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Eye disorders
Cataract
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Eye disorders
Eye allergy
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Eye disorders
Vision blurred
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
10.0%
1/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
16.7%
1/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Eye disorders
Dry eye
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Eye disorders
Iritis
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
16.7%
1/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Eye disorders
Photopsia
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
10.0%
1/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Vascular disorders
Hypertension
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.6%
1/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
50.0%
3/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic bronchitis
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
10.0%
1/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
10.0%
1/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
4.2%
3/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
16.7%
1/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
11.1%
1/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
5.2%
3/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
10.0%
1/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
10.0%
1/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
10.0%
1/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Flatulence
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Haemorrhoids
|
4.1%
3/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
10.0%
1/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
2.8%
2/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
10.0%
1/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
25.0%
1/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
25.0%
1/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Pancreatic duct dilation
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
16.7%
1/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
16.7%
1/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.7%
2/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
2.7%
2/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
10.0%
1/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
2/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
10.0%
1/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
2.8%
2/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
11.1%
1/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
5.2%
3/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
10.0%
1/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
33.3%
2/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
16.7%
1/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Musculoskeletal and connective tissue disorders
Muscoskeletal stiffness
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
16.7%
1/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Renal and urinary disorders
Micturition urgency
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.6%
1/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Reproductive system and breast disorders
Prostatitis
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
General disorders
Asthenia
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
General disorders
Catheter site inflammation
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
General disorders
Fatigue
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
4.1%
3/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
20.0%
2/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
10.0%
1/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.4%
2/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
General disorders
Impaired healing
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
General disorders
Influenza like illness
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
General disorders
Infusion site phlebitis
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
General disorders
Infusion site swelling
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
25.0%
1/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
General disorders
Malaise
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
General disorders
Pyrexia
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
General disorders
Tissue infiltration
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
General disorders
Vessel puncture site thrombosis
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
General disorders
Administration site reaction
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
General disorders
Injection site erythema
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
25.0%
1/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
General disorders
Injection site pruritus
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
25.0%
1/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
General disorders
Injection site reaction
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
General disorders
Injection site swelling
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
25.0%
1/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
General disorders
Oedema peripheral
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
11.1%
1/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
General disorders
Peripheral swelling
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
General disorders
Temperature intolerance
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Investigations
Blood pressure increased
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Investigations
Alanine aminotranferase increased
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Investigations
Blood potassium increased
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Investigations
Cardiac murmur
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
25.0%
1/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Investigations
Weight decreased
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.6%
1/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
25.0%
1/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Investigations
Weight increased
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
16.7%
1/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
6.5%
2/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
10.0%
1/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
16.7%
1/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.4%
1/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
16.7%
1/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
11.1%
1/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.4%
2/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
16.7%
1/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
16.7%
1/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
3.2%
1/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Injury, poisoning and procedural complications
Ulnar nerve injury
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/73 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/10 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/71 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/28 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/31 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/6 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/4 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
0.00%
0/9 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
|
1.7%
1/58 • Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place