Trial Outcomes & Findings for A Phase I/III Study to Evaluate Efficacy, PK and Safety Between CT-P13 SC and CT-P13 IV in Patients With Active RA (NCT NCT03147248)
NCT ID: NCT03147248
Last Updated: 2020-04-08
Results Overview
For Part 1, the primary pharmacokinetic (PK) endpoint of the AUCτ (area under the concentration-time curve) at steady state between Week 22 and Week 30 was analyzed in patients who received all doses (full) of study drug up to Week 30 (prior to Week 30) in the PK population. All patients in SC cohorts were randomly assigned at Week 14 in a 1:1 ratio to either Group A or B for PK monitoring visit period (Week 22 and Week 30). Therefore, AUCτ was calculated at Week 22 for Cohort 1: CT-P13 IV 3 mg/kg, Weeks 22 and 26 for Group A of SC cohorts, and Weeks 24 and 28 for Group B of SC cohorts.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
407 participants
Primary outcome timeframe
Weeks 22 (pre-dose to 216 hours post-dose), 24 (14 days after start of administration [SOA] at Week 22), 26 (pre-dose) and 28 (42 days after SOA at Week 22), and Week 30 (pre-dose)
Results posted on
2020-04-08
Participant Flow
Participants recruited from 21 study centers in 8 countries for Part 1. Participants recruited from 76 study centers (including 1 good clinical practice \[GCP\] noncompliant study center) in 12 countries for Part 2. The study was divided into 2 parts (Part 1 and Part 2). Thus, the patients from Part 2 were newly enrolled/randomized only for Part 2.
For Part 1, a total of 90 patients were screened, 50 patients were enrolled (40 screening failures) and 48 patients were randomized. For Part 2, a total of 528 patients were screened, 357 patients were enrolled and 343 patients were randomized. Of these, 5 patients from a significant GCP noncompliance site were excluded in all analysis population.
Participant milestones
| Measure |
Cohort 1: CT-P13 IV 3 mg/kg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 3 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54. Throughout the study, methotrexate (MTX) 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 2: CT-P13 SC 90 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 90 mg (Infliximab) by SC injection via pre-filled syringe (PFS) with a 2-week interval from Week 6. The dose of SC 90 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 2: CT-P13 SC 90 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 3: CT-P13 SC 120 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6 up to Week 54. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 4: CT-P13 SC 180 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 4: CT-P13 SC 180 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Arm 1: CT-P13 SC 120 mg (Part 2)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) by SC injection via pre-filled syringe (PFS) with a 2-week interval from Week 6 up to Week 54 with placebo IV at Weeks 6, 14, and 22. Patients in specific countries were administered CT-P13 SC via auto injector (AI) at Week 46 and every 2 weeks thereafter up to Week 54, and patients were switched back to CT-P13 SC via PFS at Week 56 and every 2 weeks thereafter up to Week 64. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Arm 2: CT-P13 IV 3 mg/kg (Part 2)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 3 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22) with placebo SC at Week 6 and every 2 weeks thereafter up to Week 28. CT-P13 IV were switched to receive CT-P13 SC via PFS at Week 30, and further doses with CT-P13 SC were given up to Week 54. Patients in specific countries were administered CT-P13 SC via AI at Week 46 and every 2 weeks thereafter up to Week 54, and patients were switched back to CT-P13 SC via PFS at Week 56 and every 2 weeks thereafter up to Week 64. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
11
|
12
|
12
|
167
|
176
|
|
Overall Study
COMPLETED
|
12
|
9
|
10
|
10
|
141
|
145
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
2
|
2
|
26
|
31
|
Reasons for withdrawal
| Measure |
Cohort 1: CT-P13 IV 3 mg/kg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 3 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54. Throughout the study, methotrexate (MTX) 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 2: CT-P13 SC 90 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 90 mg (Infliximab) by SC injection via pre-filled syringe (PFS) with a 2-week interval from Week 6. The dose of SC 90 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 2: CT-P13 SC 90 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 3: CT-P13 SC 120 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6 up to Week 54. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 4: CT-P13 SC 180 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 4: CT-P13 SC 180 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Arm 1: CT-P13 SC 120 mg (Part 2)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) by SC injection via pre-filled syringe (PFS) with a 2-week interval from Week 6 up to Week 54 with placebo IV at Weeks 6, 14, and 22. Patients in specific countries were administered CT-P13 SC via auto injector (AI) at Week 46 and every 2 weeks thereafter up to Week 54, and patients were switched back to CT-P13 SC via PFS at Week 56 and every 2 weeks thereafter up to Week 64. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Arm 2: CT-P13 IV 3 mg/kg (Part 2)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 3 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22) with placebo SC at Week 6 and every 2 weeks thereafter up to Week 28. CT-P13 IV were switched to receive CT-P13 SC via PFS at Week 30, and further doses with CT-P13 SC were given up to Week 54. Patients in specific countries were administered CT-P13 SC via AI at Week 46 and every 2 weeks thereafter up to Week 54, and patients were switched back to CT-P13 SC via PFS at Week 56 and every 2 weeks thereafter up to Week 64. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
2
|
2
|
6
|
11
|
|
Overall Study
Disease progression
|
1
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
12
|
9
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
4
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
2
|
4
|
|
Overall Study
Prolonged Dosing Interval
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
A Phase I/III Study to Evaluate Efficacy, PK and Safety Between CT-P13 SC and CT-P13 IV in Patients With Active RA
Baseline characteristics by cohort
| Measure |
Cohort 1: CT-P13 IV 3 mg/kg (Part 1)
n=13 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 3 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 2: CT-P13 SC 90 mg (Part 1)
n=11 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 90 mg (Infliximab) by SC injection via pre-filled syringe (PFS) with a 2-week interval from Week 6. The dose of SC 90 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 2: CT-P13 SC 90 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 3: CT-P13 SC 120 mg (Part 1)
n=12 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6 up to Week 54. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 4: CT-P13 SC 180 mg (Part 1)
n=12 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 4: CT-P13 SC 180 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Arm 1: CT-P13 SC 120 mg (Part 2)
n=167 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6 up to Week 54 with placebo IV at Weeks 6, 14, and 22. Patients in specific countries were administered CT-P13 SC via AI at Week 46 and every 2 weeks thereafter up to Week 54, and patients were switched back to CT-P13 SC via PFS at Week 56 and every 2 weeks thereafter up to Week 64.
Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Arm 2: CT-P13 IV 3 mg/kg (Part 2)
n=176 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 3 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22) with placebo SC at Week 6 and every 2 weeks thereafter up to Week 28. CT-P13 IV were switched to receive CT-P13 SC via PFS at Week 30, and further doses with CT-P13 SC were given up to Week 54. Patients in specific countries were administered CT-P13 SC via AI at Week 46 and every 2 weeks thereafter up to Week 54, and patients were switched back to CT-P13 SC via PFS at Week 56 and every 2 weeks thereafter up to Week 64. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Total
n=391 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
148 Participants
n=21 Participants
|
147 Participants
n=8 Participants
|
336 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
28 Participants
n=8 Participants
|
54 Participants
n=8 Participants
|
|
Age, Continuous
|
40.0 years
n=5 Participants
|
56.0 years
n=7 Participants
|
49.5 years
n=5 Participants
|
51.5 years
n=4 Participants
|
52.0 years
n=21 Participants
|
53.0 years
n=8 Participants
|
53.0 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
130 Participants
n=21 Participants
|
139 Participants
n=8 Participants
|
307 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
37 Participants
n=8 Participants
|
84 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian/Oriental
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
145 Participants
n=21 Participants
|
151 Participants
n=8 Participants
|
342 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
44 Participants
n=8 Participants
|
|
Region of Enrollment
Bosnia and Herzegovina
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
10 participants
n=21 Participants
|
11 participants
n=8 Participants
|
21 participants
n=8 Participants
|
|
Region of Enrollment
Bulgaria
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
11 participants
n=21 Participants
|
9 participants
n=8 Participants
|
20 participants
n=8 Participants
|
|
Region of Enrollment
Chile
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
4 participants
n=21 Participants
|
4 participants
n=8 Participants
|
8 participants
n=8 Participants
|
|
Region of Enrollment
Estonia
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
0 participants
n=21 Participants
|
3 participants
n=8 Participants
|
3 participants
n=8 Participants
|
|
Region of Enrollment
Hungary
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=8 Participants
|
12 participants
n=8 Participants
|
|
Region of Enrollment
South Korea
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
2 participants
n=8 Participants
|
3 participants
n=8 Participants
|
|
Region of Enrollment
Latvia
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=8 Participants
|
2 participants
n=8 Participants
|
|
Region of Enrollment
Peru
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
21 participants
n=21 Participants
|
23 participants
n=8 Participants
|
44 participants
n=8 Participants
|
|
Region of Enrollment
Poland
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
5 participants
n=4 Participants
|
46 participants
n=21 Participants
|
46 participants
n=8 Participants
|
92 participants
n=8 Participants
|
|
Region of Enrollment
Russia
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
39 participants
n=21 Participants
|
39 participants
n=8 Participants
|
78 participants
n=8 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
2 participants
n=8 Participants
|
4 participants
n=8 Participants
|
|
Region of Enrollment
Ukraine
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
27 participants
n=21 Participants
|
29 participants
n=8 Participants
|
56 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Weeks 22 (pre-dose to 216 hours post-dose), 24 (14 days after start of administration [SOA] at Week 22), 26 (pre-dose) and 28 (42 days after SOA at Week 22), and Week 30 (pre-dose)Population: The PK population consisted of the all-randomized population who received at least 1 full dose of study drug at Week 6 or thereafter and who had at least 1 PK concentration result after Week 6 treatment. Among them, patients who had AUCτ result at steady state were included for the primary analysis.
For Part 1, the primary pharmacokinetic (PK) endpoint of the AUCτ (area under the concentration-time curve) at steady state between Week 22 and Week 30 was analyzed in patients who received all doses (full) of study drug up to Week 30 (prior to Week 30) in the PK population. All patients in SC cohorts were randomly assigned at Week 14 in a 1:1 ratio to either Group A or B for PK monitoring visit period (Week 22 and Week 30). Therefore, AUCτ was calculated at Week 22 for Cohort 1: CT-P13 IV 3 mg/kg, Weeks 22 and 26 for Group A of SC cohorts, and Weeks 24 and 28 for Group B of SC cohorts.
Outcome measures
| Measure |
Cohort 1: CT-P13 IV 3 mg/kg (Part 1)
n=13 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 3 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54. Throughout the study, methotrexate (MTX) 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 2: CT-P13 SC 90 mg (Part 1)
n=10 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 90 mg (Infliximab) by SC injection via pre-filled syringe (PFS) with a 2-week interval from Week 6. The dose of SC 90 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 2: CT-P13 SC 90 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 3: CT-P13 SC 120 mg (Part 1)
n=11 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6 up to Week 54. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 4: CT-P13 SC 180 mg (Part 1)
n=12 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 4: CT-P13 SC 180 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1)
Week 24
|
—
|
3272936.8 hr*ng/mL
Standard Deviation 2847811.60
|
4835631.9 hr*ng/mL
Standard Deviation 2156587.25
|
9322764.3 hr*ng/mL
Standard Deviation 2704651.44
|
|
Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1)
Week 22
|
12032957.5 hr*ng/mL
Standard Deviation 5345598.59
|
5047724.2 hr*ng/mL
Standard Deviation 2449771.86
|
7333767.0 hr*ng/mL
Standard Deviation 2765064.19
|
9930696.6 hr*ng/mL
Standard Deviation 3208367.37
|
|
Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1)
Week 26
|
—
|
4722645.2 hr*ng/mL
Standard Deviation 2434832.19
|
7295570.5 hr*ng/mL
Standard Deviation 2261574.63
|
10402980.9 hr*ng/mL
Standard Deviation 3316415.11
|
|
Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1)
Week 28
|
—
|
3231316.6 hr*ng/mL
Standard Deviation 2582286.88
|
5076458.7 hr*ng/mL
Standard Deviation 2733359.45
|
10578411.8 hr*ng/mL
Standard Deviation 3443240.82
|
PRIMARY outcome
Timeframe: Week 22Population: Efficacy population consisted of all randomly assigned patients who received at least 1 full dose of study drug at Week 6 or thereafter and had at least 1 efficacy result after Week 6. Among them, patients who had DAS28 (CRP) at Week 22 were included for the analysis. All patients were analyzed according to the treatment they received.
For Part 2, the primary efficacy endpoint was to demonstrate that CT-P13 SC 120 mg is non-inferior to CT-P13 IV 3 mg/kg at Week 22, as determined by clinical response according to mean change from baseline in DAS28 (CRP) at Week 22, using Analysis of Covariance (ANCOVA). Change from baseline for ANCOVA was defined as decrease from baseline and calculated as (DAS28 \[CRP\] at baseline - DAS28 \[CRP\] at Week 22). DAS28 (CRP) was calculated using the following formula: DAS28 (CRP) equals(=) (0.56 multiplied by \[\*\] the square root \[√\] of TJC28 \[tender joint count\]) plus (+) (0.28 \* √ of SJC28 \[swollen joint count\]) + (0.36 \* the natural logarithm \[ln\](CRP \[mg/L\] + 1)) + (0.014 \* patient global disease activity \[GH\] on visual analogue assessment \[VAS\]) + 0.96. DAS28 (CRP) provides a number on a scale from 0 to 10 indicating the current activity of patients with RA. DAS28 (CRP) score above 5.1 indicates high disease activity, whereas DAS28 (CRP) score below 3.2 indicates low disease activity.
Outcome measures
| Measure |
Cohort 1: CT-P13 IV 3 mg/kg (Part 1)
n=162 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 3 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54. Throughout the study, methotrexate (MTX) 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 2: CT-P13 SC 90 mg (Part 1)
n=168 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 90 mg (Infliximab) by SC injection via pre-filled syringe (PFS) with a 2-week interval from Week 6. The dose of SC 90 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 2: CT-P13 SC 90 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 3: CT-P13 SC 120 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6 up to Week 54. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 4: CT-P13 SC 180 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 4: CT-P13 SC 180 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
|---|---|---|---|---|
|
Change From Baseline of Disease Activity Score Using 28 Joint Counts (DAS28) (CRP) at Week 22 (Part 2)
|
2.21 score on a scale
Standard Error 0.221
|
1.94 score on a scale
Standard Error 0.209
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 14, Week 22, Week 30, and Week 54Population: The efficacy population consisted of all randomly assigned patients who received at least 1 full dose of study drug (CT-P13 IV or CT-P13 SC) at Week 6 or thereafter, and who had at least 1 efficacy evaluation result after Week 6 and thereafter treatment. All patients in efficacy population were analyzed according to the treatment they received.
The secondary endpoint was defined as descriptive statistics of actual value in disease activity measured by DAS28 (CRP) up to Week 54. The results up to Week 6 represented the efficacy of CT-P13 IV loading dose (3 mg/kg) regardless of randomized treatment arm (CT-P13 SC or CT-P13 IV) in both treatment arms. DAS28 (CRP) was calculated according to the following formula: DAS28 (CRP) = (0.56\* √ of TJC28) + (0.28 \* √ of SJC28) + (0.36 \* ln(CRP \[mg/L\] + 1)) + (0.014 \* GH on VAS) + 0.96. DAS28 (CRP) provides a number on a scale from 0 to 10 indicating the current activity of the patients with RA. DAS28 (CRP) score above 5.1 indicates high disease activity, whereas DAS28 (CRP) score below 3.2 indicates low disease activity.
Outcome measures
| Measure |
Cohort 1: CT-P13 IV 3 mg/kg (Part 1)
n=165 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 3 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54. Throughout the study, methotrexate (MTX) 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 2: CT-P13 SC 90 mg (Part 1)
n=174 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 90 mg (Infliximab) by SC injection via pre-filled syringe (PFS) with a 2-week interval from Week 6. The dose of SC 90 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 2: CT-P13 SC 90 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 3: CT-P13 SC 120 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6 up to Week 54. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 4: CT-P13 SC 180 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 4: CT-P13 SC 180 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
|---|---|---|---|---|
|
Mean Actual Value of Disease Activity Score Using 28 Joint Counts (DAS28 [CRP]) (Part 2)
Baseline
|
6.0 score on a scale
Standard Deviation 0.75
|
5.9 score on a scale
Standard Deviation 0.81
|
—
|
—
|
|
Mean Actual Value of Disease Activity Score Using 28 Joint Counts (DAS28 [CRP]) (Part 2)
Week 2
|
4.7 score on a scale
Standard Deviation 0.94
|
4.6 score on a scale
Standard Deviation 1.05
|
—
|
—
|
|
Mean Actual Value of Disease Activity Score Using 28 Joint Counts (DAS28 [CRP]) (Part 2)
Week 6
|
4.0 score on a scale
Standard Deviation 1.20
|
4.1 score on a scale
Standard Deviation 1.21
|
—
|
—
|
|
Mean Actual Value of Disease Activity Score Using 28 Joint Counts (DAS28 [CRP]) (Part 2)
Week 14
|
3.5 score on a scale
Standard Deviation 1.20
|
3.7 score on a scale
Standard Deviation 1.25
|
—
|
—
|
|
Mean Actual Value of Disease Activity Score Using 28 Joint Counts (DAS28 [CRP]) (Part 2)
Week 22
|
3.3 score on a scale
Standard Deviation 1.10
|
3.5 score on a scale
Standard Deviation 1.23
|
—
|
—
|
|
Mean Actual Value of Disease Activity Score Using 28 Joint Counts (DAS28 [CRP]) (Part 2)
Week 30
|
3.0 score on a scale
Standard Deviation 1.13
|
3.5 score on a scale
Standard Deviation 1.23
|
—
|
—
|
|
Mean Actual Value of Disease Activity Score Using 28 Joint Counts (DAS28 [CRP]) (Part 2)
Week 54
|
2.8 score on a scale
Standard Deviation 1.14
|
2.9 score on a scale
Standard Deviation 1.16
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 2, Week 6, Week 14, Week 22, Week 30, and Week 54Population: The efficacy population consisted of all randomly assigned patients who received at least 1 full dose of study drug (CT-P13 IV or CT-P13 SC) at Week 6 or thereafter, and who had at least 1 efficacy evaluation result after Week 6 and thereafter treatment. All patients in efficacy population were analyzed according to the treatment they received.
The secondary endpoint was defined as number of patients achieving clinical response according to ACR20 (20% response, defined by ACR) between CT-P13 SC and CT-P13 IV groups. The results up to Week 6 represented the efficacy of CT-P13 IV loading dose (3 mg/kg) regardless of randomized treatment arm (CT-P13 SC or CT-P13 IV). Responder according to the ACR20 criteria defined as, if they are fulfilled, a decrease of at least 20% in number of tender joints and swollen joints (0-28), and 20% improvement in 3 of the followings: patient assessment of pain on VAS (0-100 mm), patient global assessment of disease activity on VAS (0-100 mm) and physician global assessment of disease activity on VAS (0-100 mm), health assessment questionnaire disability index and CRP or ESR (erythrocyte sedimentation rate).
Outcome measures
| Measure |
Cohort 1: CT-P13 IV 3 mg/kg (Part 1)
n=165 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 3 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54. Throughout the study, methotrexate (MTX) 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 2: CT-P13 SC 90 mg (Part 1)
n=174 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 90 mg (Infliximab) by SC injection via pre-filled syringe (PFS) with a 2-week interval from Week 6. The dose of SC 90 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 2: CT-P13 SC 90 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 3: CT-P13 SC 120 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6 up to Week 54. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 4: CT-P13 SC 180 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 4: CT-P13 SC 180 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
|---|---|---|---|---|
|
Number of Patients Achieving Clinical Response According to American College of Rheumatology 20% Response (ACR20) (Part 2)
Week 2
|
63 Participants
|
57 Participants
|
—
|
—
|
|
Number of Patients Achieving Clinical Response According to American College of Rheumatology 20% Response (ACR20) (Part 2)
Week 6
|
107 Participants
|
103 Participants
|
—
|
—
|
|
Number of Patients Achieving Clinical Response According to American College of Rheumatology 20% Response (ACR20) (Part 2)
Week 14
|
124 Participants
|
130 Participants
|
—
|
—
|
|
Number of Patients Achieving Clinical Response According to American College of Rheumatology 20% Response (ACR20) (Part 2)
Week 22
|
139 Participants
|
137 Participants
|
—
|
—
|
|
Number of Patients Achieving Clinical Response According to American College of Rheumatology 20% Response (ACR20) (Part 2)
Week 30
|
142 Participants
|
133 Participants
|
—
|
—
|
|
Number of Patients Achieving Clinical Response According to American College of Rheumatology 20% Response (ACR20) (Part 2)
Week 54
|
132 Participants
|
125 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: SC group: Weeks 0, 2, 12, 20, 22, 24, 26, 28, 36, 44, and 52; IV group: Weeks 0, 2, 6, 14, 22, 36, 44, and 52Population: The PK population consisted of all randomly assigned patients who received at least 1 full dose of study drug (CT-P13 IV, CT-P13 SC) at Week 6 or thereafter and who had at least 1 PK concentration result after Week 6 or thereafter treatment. All patients in PK population were analyzed according to the treatment they received.
For evaluation of pharmacokinetics (PK), the secondary endpoint was defined as the analysis of trough concentration (concentration before the next study drug administration) of Infliximab up to Week 54. The samples were collected at Weeks 0, 2 and 6, and every 8 weeks up to Week 54. During PK monitoring visit (Weeks 22-30), samples were collected every 2 weeks according steady state PK sampling time point. All patients were randomly assigned at Week 14 in a 1:1:1:1 ratio to one of 4 groups (Groups A, B, C or D) for PK monitoring visit period. No PK results were obtained at Weeks 6 and 14 for SC group and Weeks 12, 20, 24, 26 and 28 for IV group due to 2 weeks and 8 weeks dosing interval, respectively.
Outcome measures
| Measure |
Cohort 1: CT-P13 IV 3 mg/kg (Part 1)
n=166 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 3 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54. Throughout the study, methotrexate (MTX) 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 2: CT-P13 SC 90 mg (Part 1)
n=174 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 90 mg (Infliximab) by SC injection via pre-filled syringe (PFS) with a 2-week interval from Week 6. The dose of SC 90 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 2: CT-P13 SC 90 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 3: CT-P13 SC 120 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6 up to Week 54. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 4: CT-P13 SC 180 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 4: CT-P13 SC 180 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
|---|---|---|---|---|
|
Observed Trough Serum Concentration (Ctrough) of Infliximab (Part 2)
Week 0
|
15.73 μg/mL
Standard Deviation 5.83
|
16.00 μg/mL
Standard Deviation 5.99
|
—
|
—
|
|
Observed Trough Serum Concentration (Ctrough) of Infliximab (Part 2)
Week 2
|
8.64 μg/mL
Standard Deviation 5.97
|
8.81 μg/mL
Standard Deviation 7.13
|
—
|
—
|
|
Observed Trough Serum Concentration (Ctrough) of Infliximab (Part 2)
Week 6
|
—
|
1.89 μg/mL
Standard Deviation 2.61
|
—
|
—
|
|
Observed Trough Serum Concentration (Ctrough) of Infliximab (Part 2)
Week 12
|
12.33 μg/mL
Standard Deviation 8.20
|
—
|
—
|
—
|
|
Observed Trough Serum Concentration (Ctrough) of Infliximab (Part 2)
Week 14
|
—
|
3.20 μg/mL
Standard Deviation 11.14
|
—
|
—
|
|
Observed Trough Serum Concentration (Ctrough) of Infliximab (Part 2)
Week 20
|
12.72 μg/mL
Standard Deviation 9.13
|
—
|
—
|
—
|
|
Observed Trough Serum Concentration (Ctrough) of Infliximab (Part 2)
Week 22
|
13.19 μg/mL
Standard Deviation 10.57
|
1.03 μg/mL
Standard Deviation 1.85
|
—
|
—
|
|
Observed Trough Serum Concentration (Ctrough) of Infliximab (Part 2)
Week 24
|
12.32 μg/mL
Standard Deviation 8.55
|
—
|
—
|
—
|
|
Observed Trough Serum Concentration (Ctrough) of Infliximab (Part 2)
Week 26
|
10.73 μg/mL
Standard Deviation 7.08
|
—
|
—
|
—
|
|
Observed Trough Serum Concentration (Ctrough) of Infliximab (Part 2)
Week 28
|
12.27 μg/mL
Standard Deviation 9.75
|
—
|
—
|
—
|
|
Observed Trough Serum Concentration (Ctrough) of Infliximab (Part 2)
Week 36
|
12.20 μg/mL
Standard Deviation 9.44
|
8.79 μg/mL
Standard Deviation 8.63
|
—
|
—
|
|
Observed Trough Serum Concentration (Ctrough) of Infliximab (Part 2)
Week 44
|
11.24 μg/mL
Standard Deviation 8.51
|
9.97 μg/mL
Standard Deviation 9.65
|
—
|
—
|
|
Observed Trough Serum Concentration (Ctrough) of Infliximab (Part 2)
Week 52
|
10.98 μg/mL
Standard Deviation 8.81
|
10.23 μg/mL
Standard Deviation 10.08
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 14, Week 22, Week 30, Week 38, Week 46, and Week 54Population: The PD population consisted of all randomized population who received at least 1 full dose of study drug at Week 6 or thereafter and had at least 1 PD result (rheumatoid factor, anti-cyclic citrullinated peptide, CRP or ESR) after Week 6 treatment. All patients in PD population were analyzed according to the treatment they received.
For evaluation of pharmacodynamic (PD), the secondary endpoint was defined as concentration of CRP between 2 treatment groups up to Week 54. The blood samples for CRP were collected at Weeks 0, 2 and 6, and every 8 weeks up to Week 54. Patient who received the other treatment than that to which they were assigned at any point was defined as mis-randomized. One patient in IV group was mis-randomized and analyzed as SC group for PD analysis.
Outcome measures
| Measure |
Cohort 1: CT-P13 IV 3 mg/kg (Part 1)
n=168 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 3 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54. Throughout the study, methotrexate (MTX) 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 2: CT-P13 SC 90 mg (Part 1)
n=175 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 90 mg (Infliximab) by SC injection via pre-filled syringe (PFS) with a 2-week interval from Week 6. The dose of SC 90 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 2: CT-P13 SC 90 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 3: CT-P13 SC 120 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6 up to Week 54. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 4: CT-P13 SC 180 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 4: CT-P13 SC 180 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
|---|---|---|---|---|
|
Mean Actual Value in Serum CRP Concentration (Pharmacodynamic Parameter) (Part 2)
Baseline
|
1.82 mg/dL
Standard Deviation 2.37
|
2.23 mg/dL
Standard Deviation 3.52
|
—
|
—
|
|
Mean Actual Value in Serum CRP Concentration (Pharmacodynamic Parameter) (Part 2)
Week 2
|
0.47 mg/dL
Standard Deviation 0.78
|
0.62 mg/dL
Standard Deviation 1.43
|
—
|
—
|
|
Mean Actual Value in Serum CRP Concentration (Pharmacodynamic Parameter) (Part 2)
Week 6
|
0.74 mg/dL
Standard Deviation 1.38
|
0.98 mg/dL
Standard Deviation 1.84
|
—
|
—
|
|
Mean Actual Value in Serum CRP Concentration (Pharmacodynamic Parameter) (Part 2)
Week 14
|
0.81 mg/dL
Standard Deviation 1.96
|
1.14 mg/dL
Standard Deviation 2.53
|
—
|
—
|
|
Mean Actual Value in Serum CRP Concentration (Pharmacodynamic Parameter) (Part 2)
Week 22
|
0.72 mg/dL
Standard Deviation 1.33
|
1.16 mg/dL
Standard Deviation 2.13
|
—
|
—
|
|
Mean Actual Value in Serum CRP Concentration (Pharmacodynamic Parameter) (Part 2)
Week 30
|
0.67 mg/dL
Standard Deviation 1.26
|
1.17 mg/dL
Standard Deviation 2.14
|
—
|
—
|
|
Mean Actual Value in Serum CRP Concentration (Pharmacodynamic Parameter) (Part 2)
Week 38
|
0.71 mg/dL
Standard Deviation 1.28
|
1.08 mg/dL
Standard Deviation 2.95
|
—
|
—
|
|
Mean Actual Value in Serum CRP Concentration (Pharmacodynamic Parameter) (Part 2)
Week 46
|
0.60 mg/dL
Standard Deviation 1.01
|
0.79 mg/dL
Standard Deviation 1.47
|
—
|
—
|
|
Mean Actual Value in Serum CRP Concentration (Pharmacodynamic Parameter) (Part 2)
Week 54
|
0.60 mg/dL
Standard Deviation 1.01
|
0.78 mg/dL
Standard Deviation 1.48
|
—
|
—
|
Adverse Events
Cohort 1: CT-P13 IV 3 mg/kg (Part 1)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 2: CT-P13 SC 90 mg (Part 1)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 3: CT-P13 SC 120 mg (Part 1)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 4: CT-P13 SC 180 mg (Part 1)
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Arm 1: CT-P13 SC 120 mg (Part 2)
Serious events: 6 serious events
Other events: 91 other events
Deaths: 1 deaths
Arm 2: CT-P13 IV 3 mg/kg (Part 2)
Serious events: 14 serious events
Other events: 90 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Cohort 1: CT-P13 IV 3 mg/kg (Part 1)
n=13 participants at risk
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 3 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54. Throughout the study, methotrexate (MTX) 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 2: CT-P13 SC 90 mg (Part 1)
n=11 participants at risk
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 90 mg (Infliximab) by SC injection via pre-filled syringe (PFS) with a 2-week interval from Week 6. The dose of SC 90 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 2: CT-P13 SC 90 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 3: CT-P13 SC 120 mg (Part 1)
n=12 participants at risk
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6 up to Week 54. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 4: CT-P13 SC 180 mg (Part 1)
n=12 participants at risk
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 4: CT-P13 SC 180 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Arm 1: CT-P13 SC 120 mg (Part 2)
n=168 participants at risk
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) by SC injection via pre-filled syringe (PFS) with a 2-week interval from Week 6 up to Week 54 with placebo IV at Weeks 6, 14, and 22. Patients in specific countries were administered CT-P13 SC via auto injector (AI) at Week 46 and every 2 weeks thereafter up to Week 54, and patients were switched back to CT-P13 SC via PFS at Week 56 and every 2 weeks thereafter up to Week 64. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Arm 2: CT-P13 IV 3 mg/kg (Part 2)
n=175 participants at risk
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 3 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22) with placebo SC at Week 6 and every 2 weeks thereafter up to Week 28. CT-P13 IV were switched to receive CT-P13 SC via PFS at Week 30, and further doses with CT-P13 SC were given up to Week 54. Patients in specific countries were administered CT-P13 SC via AI at Week 46 and every 2 weeks thereafter up to Week 54, and patients were switched back to CT-P13 SC via PFS at Week 56 and every 2 weeks thereafter up to Week 64. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.60%
1/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.57%
1/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.57%
1/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.1%
2/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Congenital, familial and genetic disorders
Hereditary haemochromatosis
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.60%
1/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.1%
2/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.60%
1/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.60%
1/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
General disorders
Sudden death
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.57%
1/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Infections and infestations
Influenza
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.57%
1/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Infections and infestations
Pertussis
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.57%
1/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.2%
2/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.60%
1/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.57%
1/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.57%
1/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.57%
1/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.57%
1/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.57%
1/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.57%
1/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Product Issues
Device loosening
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.60%
1/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.57%
1/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Blood and lymphatic system disorders
Antiphospholipid syndrome
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Infections and infestations
Latent tuberculosis
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
9.1%
1/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
9.1%
1/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
Other adverse events
| Measure |
Cohort 1: CT-P13 IV 3 mg/kg (Part 1)
n=13 participants at risk
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 3 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54. Throughout the study, methotrexate (MTX) 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 2: CT-P13 SC 90 mg (Part 1)
n=11 participants at risk
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 90 mg (Infliximab) by SC injection via pre-filled syringe (PFS) with a 2-week interval from Week 6. The dose of SC 90 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 2: CT-P13 SC 90 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 3: CT-P13 SC 120 mg (Part 1)
n=12 participants at risk
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6 up to Week 54. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Cohort 4: CT-P13 SC 180 mg (Part 1)
n=12 participants at risk
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 4: CT-P13 SC 180 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Arm 1: CT-P13 SC 120 mg (Part 2)
n=168 participants at risk
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) by SC injection via pre-filled syringe (PFS) with a 2-week interval from Week 6 up to Week 54 with placebo IV at Weeks 6, 14, and 22. Patients in specific countries were administered CT-P13 SC via auto injector (AI) at Week 46 and every 2 weeks thereafter up to Week 54, and patients were switched back to CT-P13 SC via PFS at Week 56 and every 2 weeks thereafter up to Week 64. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
Arm 2: CT-P13 IV 3 mg/kg (Part 2)
n=175 participants at risk
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 3 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22) with placebo SC at Week 6 and every 2 weeks thereafter up to Week 28. CT-P13 IV were switched to receive CT-P13 SC via PFS at Week 30, and further doses with CT-P13 SC were given up to Week 54. Patients in specific countries were administered CT-P13 SC via AI at Week 46 and every 2 weeks thereafter up to Week 54, and patients were switched back to CT-P13 SC via PFS at Week 56 and every 2 weeks thereafter up to Week 64. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
3.6%
6/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
2.3%
4/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
General disorders
Localized injection site reaction
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
18.2%
2/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
16.7%
2/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
17.9%
30/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
12.6%
22/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
9.1%
1/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
4.2%
7/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
2.3%
4/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Infections and infestations
Latent tuberculosis
|
7.7%
1/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
4.8%
8/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
5.7%
10/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Infections and infestations
Oral herpes
|
7.7%
1/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
4.2%
7/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
2.3%
4/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Infections and infestations
Upper respiratory tract infection
|
15.4%
2/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
9.1%
1/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
16.7%
2/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
5.4%
9/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
7.4%
13/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
18.2%
2/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
5.4%
9/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
5.1%
9/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
15.4%
2/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
25.0%
3/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
7.7%
13/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
9.1%
16/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
15.4%
2/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.2%
2/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
5.1%
9/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
4.8%
8/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
6.3%
11/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
9.1%
1/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.8%
3/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
4.0%
7/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
30.8%
4/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
4.8%
8/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
4.6%
8/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
9.1%
1/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
4.2%
7/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
6.3%
11/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.8%
3/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.7%
3/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.7%
1/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.60%
1/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
9.1%
1/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.2%
2/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.57%
1/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
7.7%
1/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.7%
1/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.7%
3/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
16.7%
2/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
2.4%
4/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.57%
1/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Gastrointestinal disorders
Flatulence
|
7.7%
1/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.60%
1/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Gastrointestinal disorders
Gastritis
|
7.7%
1/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.60%
1/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
2.4%
4/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.1%
2/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
General disorders
Influenza like illness
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
General disorders
Pyrexia
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
16.7%
2/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.1%
2/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Infections and infestations
Angular cheilitis
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Infections and infestations
Cystitis
|
7.7%
1/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.7%
3/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Infections and infestations
Influenza
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
9.1%
1/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.60%
1/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.7%
3/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Infections and infestations
Otosalpingitis
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Infections and infestations
Pharyngitis
|
7.7%
1/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.8%
3/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.1%
2/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.60%
1/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.1%
2/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.2%
2/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.57%
1/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Infections and infestations
Wound infection
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
9.1%
1/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
9.1%
1/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Injury, poisoning and procedural complications
Systemic injection reaction
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
9.1%
1/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.2%
2/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.7%
3/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
9.1%
1/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.8%
3/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.1%
2/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Investigations
Electrocardiogram abnormal
|
7.7%
1/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
9.1%
1/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.8%
3/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.7%
3/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Investigations
Glucose urine
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
9.1%
1/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Investigations
Transaminases increased
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.60%
1/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.7%
3/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Investigations
Weight decreased
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
1/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.2%
2/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.57%
1/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
7.7%
1/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.7%
1/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Nervous system disorders
Radiculopathy
|
7.7%
1/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
9.1%
1/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.57%
1/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.7%
1/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.2%
2/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.57%
1/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.57%
1/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
1/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.60%
1/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.1%
2/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Vascular disorders
Hypertension
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
9.1%
1/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
1.8%
3/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
2.3%
4/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Investigations
Beta-2 glycoprotein antibody positive
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
8.3%
1/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
|
Injury, poisoning and procedural complications
Delayed hypersensitivity
|
0.00%
0/13 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
18.2%
2/11 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
16.7%
2/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.00%
0/12 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
3.0%
5/168 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
0.57%
1/175 • Adverse events (AEs) and serious adverse events (SAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit. The duration of the study was up to Week 62 for Part 1, and the study duration for Part 2 was up to Week 66 per country.
Investigator was responsible for reporting all AEs that were observed during the study regardless of their relationship to study drug/clinical significance. Safety analysis was pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis. But, for Part 2, one patient in IV group was mis-randomized and analyzed as SC group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place