Trial Outcomes & Findings for A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis (NCT NCT03789292)
NCT ID: NCT03789292
Last Updated: 2021-11-17
Results Overview
ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
648 participants
Primary outcome timeframe
Week 24
Results posted on
2021-11-17
Participant Flow
Participant milestones
| Measure |
CT-P17 Subcutaneous(SC) (Adalimumab)
Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24.
Treatment Period 2: All patients who were initially randomly assigned to CT-P17 (40mg/0.4mL) at Day 1 (Week 0) continued their treatment with CT-P17 from Week 26 up to Week 48.
|
EU-approved Humira SC (Adalimumab)
Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24.
Treatment Period 2: Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.
|
Switched to CT-P17
Treatment Period 1: N/A
Treatment Period 2: Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.
|
|---|---|---|---|
|
Treatment Period I (Week 0 to Week 26)
STARTED
|
324
|
324
|
0
|
|
Treatment Period I (Week 0 to Week 26)
COMPLETED
|
303
|
305
|
0
|
|
Treatment Period I (Week 0 to Week 26)
NOT COMPLETED
|
21
|
19
|
0
|
|
Treatment Period II (Week 26 to Week 52)
STARTED
|
303
|
153
|
152
|
|
Treatment Period II (Week 26 to Week 52)
COMPLETED
|
287
|
147
|
143
|
|
Treatment Period II (Week 26 to Week 52)
NOT COMPLETED
|
16
|
6
|
9
|
Reasons for withdrawal
| Measure |
CT-P17 Subcutaneous(SC) (Adalimumab)
Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24.
Treatment Period 2: All patients who were initially randomly assigned to CT-P17 (40mg/0.4mL) at Day 1 (Week 0) continued their treatment with CT-P17 from Week 26 up to Week 48.
|
EU-approved Humira SC (Adalimumab)
Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24.
Treatment Period 2: Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.
|
Switched to CT-P17
Treatment Period 1: N/A
Treatment Period 2: Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.
|
|---|---|---|---|
|
Treatment Period I (Week 0 to Week 26)
Adverse Event
|
7
|
8
|
0
|
|
Treatment Period I (Week 0 to Week 26)
Lost to Follow-up
|
2
|
0
|
0
|
|
Treatment Period I (Week 0 to Week 26)
Physician Decision
|
1
|
0
|
0
|
|
Treatment Period I (Week 0 to Week 26)
Protocol Violation
|
1
|
1
|
0
|
|
Treatment Period I (Week 0 to Week 26)
Withdrawal by Subject
|
9
|
8
|
0
|
|
Treatment Period I (Week 0 to Week 26)
Significant dose delay
|
1
|
0
|
0
|
|
Treatment Period I (Week 0 to Week 26)
Patient decision
|
0
|
2
|
0
|
|
Treatment Period II (Week 26 to Week 52)
Adverse Event
|
3
|
3
|
6
|
|
Treatment Period II (Week 26 to Week 52)
Lost to Follow-up
|
0
|
0
|
1
|
|
Treatment Period II (Week 26 to Week 52)
Physician Decision
|
1
|
0
|
0
|
|
Treatment Period II (Week 26 to Week 52)
Withdrawal by Subject
|
9
|
2
|
2
|
|
Treatment Period II (Week 26 to Week 52)
Significant dose delay
|
1
|
0
|
0
|
|
Treatment Period II (Week 26 to Week 52)
Could not visit the site due to COVID-19 pandemic
|
2
|
1
|
0
|
Baseline Characteristics
A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
CT-P17
n=324 Participants
Patients were administered CT-P17 (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.
|
EU-approved Humira
n=324 Participants
Patients were administered EU-approved Humira (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.
|
Total
n=648 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
268 Participants
n=5 Participants
|
282 Participants
n=7 Participants
|
550 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
55 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Age, Continuous
|
53.5 years
n=5 Participants
|
54.0 years
n=7 Participants
|
54.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
249 Participants
n=5 Participants
|
265 Participants
n=7 Participants
|
514 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
299 Participants
n=5 Participants
|
298 Participants
n=7 Participants
|
597 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Peru
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
231 Participants
n=5 Participants
|
231 Participants
n=7 Participants
|
462 Participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Intent-to-Treat (ITT) population.
ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)
Outcome measures
| Measure |
CT-P17 Subcutaneous(SC) (Adalimumab)
n=324 Participants
Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24.
Treatment Period 2: All patients who were initially randomly assigned to CT-P17 (40mg/0.4mL) at Day 1 (Week 0) continued their treatment with CT-P17 from Week 26 up to Week 48.
|
EU-approved Humira SC (Adalimumab)
n=324 Participants
Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24.
Treatment Period 2: Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.
|
Switched to CT-P17
Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.
|
|---|---|---|---|
|
American College of Rheumatology(ACR)20 Response Rate at Week 24.
|
268 Participants
|
268 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Intent-to-Treat (ITT) population.
ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.
Outcome measures
| Measure |
CT-P17 Subcutaneous(SC) (Adalimumab)
n=324 Participants
Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24.
Treatment Period 2: All patients who were initially randomly assigned to CT-P17 (40mg/0.4mL) at Day 1 (Week 0) continued their treatment with CT-P17 from Week 26 up to Week 48.
|
EU-approved Humira SC (Adalimumab)
n=324 Participants
Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24.
Treatment Period 2: Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.
|
Switched to CT-P17
Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.
|
|---|---|---|---|
|
ACR50 and ACR70 Response Rate at Week 24
ACR50 at Week 24
|
195 Participants
|
206 Participants
|
—
|
|
ACR50 and ACR70 Response Rate at Week 24
ACR70 at Week 24
|
132 Participants
|
144 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 52Population: Intent-to-Treat (ITT) population.
ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.
Outcome measures
| Measure |
CT-P17 Subcutaneous(SC) (Adalimumab)
n=303 Participants
Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24.
Treatment Period 2: All patients who were initially randomly assigned to CT-P17 (40mg/0.4mL) at Day 1 (Week 0) continued their treatment with CT-P17 from Week 26 up to Week 48.
|
EU-approved Humira SC (Adalimumab)
n=153 Participants
Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24.
Treatment Period 2: Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.
|
Switched to CT-P17
n=152 Participants
Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.
|
|---|---|---|---|
|
ACR20, ACR50, and ACR70 Response Rate up to Week 52
ACR20 at Week 52
|
244 Participants
|
119 Participants
|
125 Participants
|
|
ACR20, ACR50, and ACR70 Response Rate up to Week 52
ACR50 at Week 52
|
201 Participants
|
95 Participants
|
101 Participants
|
|
ACR20, ACR50, and ACR70 Response Rate up to Week 52
ACR70 at Week 52
|
135 Participants
|
75 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: Intent-to-Treat (ITT) population.
The Disease activity score (DAS28) (c-reactive protein \[CRP\]) score was derived using the following formulae: DAS28 (CRP) = 0.56\*√(TJC28) + 0.28\*√(SJC28) + 0.014\*(GH) + 0.36\*ln(CRP+1) + 0.96 Where: TJC28 = 28 joint count for tenderness (0-28) SJC28 = 28 joint count for swelling (0-28) Ln (CRP) = natural logarithm of CRP (mg/L : 0.2-236.3 as observed in the study) GH = General Health component of the DAS (patient's global assessment of disease activity) (mm: 0-100). DAS28 (CRP) values range from 1.03 to 8.77 while higher values mean a higher disease activity.
Outcome measures
| Measure |
CT-P17 Subcutaneous(SC) (Adalimumab)
n=324 Participants
Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24.
Treatment Period 2: All patients who were initially randomly assigned to CT-P17 (40mg/0.4mL) at Day 1 (Week 0) continued their treatment with CT-P17 from Week 26 up to Week 48.
|
EU-approved Humira SC (Adalimumab)
n=324 Participants
Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24.
Treatment Period 2: Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.
|
Switched to CT-P17
Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.
|
|---|---|---|---|
|
Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP)
|
-2.738 Units on a scale
Standard Deviation 1.1911
|
-2.734 Units on a scale
Standard Deviation 1.2052
|
—
|
SECONDARY outcome
Timeframe: Up to Week 52Population: Intent-to-Treat (ITT) population.
The Disease activity score (DAS28) (c-reactive protein \[CRP\]) score was derived using the following formulae: DAS28 (CRP) = 0.56\*√(TJC28) + 0.28\*√(SJC28) + 0.014\*(GH) + 0.36\*ln(CRP+1) + 0.96 Where: TJC28 = 28 joint count for tenderness (0-28) SJC28 = 28 joint count for swelling (0-28) Ln (CRP) = natural logarithm of CRP (mg/L : 0.2-236.3 as observed in the study) GH = General Health component of the DAS (patient's global assessment of disease activity) (mm: 0-100). DAS28 (CRP) values range from 1.03 to 8.77 while higher values mean a higher disease activity.
Outcome measures
| Measure |
CT-P17 Subcutaneous(SC) (Adalimumab)
n=303 Participants
Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24.
Treatment Period 2: All patients who were initially randomly assigned to CT-P17 (40mg/0.4mL) at Day 1 (Week 0) continued their treatment with CT-P17 from Week 26 up to Week 48.
|
EU-approved Humira SC (Adalimumab)
n=153 Participants
Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24.
Treatment Period 2: Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.
|
Switched to CT-P17
n=152 Participants
Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.
|
|---|---|---|---|
|
Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP)
|
-2.945 Units on a scale
Standard Deviation 1.1273
|
-3.074 Units on a scale
Standard Deviation 1.1926
|
-2.983 Units on a scale
Standard Deviation 1.2529
|
Adverse Events
Treatment 1: CT-P17
Serious events: 12 serious events
Other events: 96 other events
Deaths: 0 deaths
Treatment 1: EU-approved Humira
Serious events: 19 serious events
Other events: 118 other events
Deaths: 0 deaths
Treatment 2: CT-P17 Maintenance
Serious events: 6 serious events
Other events: 50 other events
Deaths: 0 deaths
Treatment 2: Humira Maintenance
Serious events: 3 serious events
Other events: 35 other events
Deaths: 0 deaths
Treatment 2: Switched to CT-P17
Serious events: 5 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment 1: CT-P17
n=324 participants at risk
Patients were administered CT-P17 (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.
|
Treatment 1: EU-approved Humira
n=324 participants at risk
Patients were administered EU-approved Humira (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.
|
Treatment 2: CT-P17 Maintenance
n=303 participants at risk
All patients who were initially randomly assigned to CT-P17 (40mg/0.4mL) at Day 1 (Week 0) continued their treatment with CT-P17 from Week 26 up to Week 48.
|
Treatment 2: Humira Maintenance
n=152 participants at risk
Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.
|
Treatment 2: Switched to CT-P17
n=152 participants at risk
Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.33%
1/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.66%
1/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Eye disorders
Retinal vein thrombosis
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.66%
1/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Eye disorders
Vitreous hemorrhage
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Gastrointestinal disorders
Abdominal pain
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Hepatobiliary disorders
Hepatic failure
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Hepatobiliary disorders
Nonalcoholic fatty liver disease
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Infections and infestations
Breast abscess
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.66%
1/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Infections and infestations
Bronchitis
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Infections and infestations
Cellulitis
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Infections and infestations
Chronic tonsillitis
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Infections and infestations
Epididymitis
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Infections and infestations
Erysipelas
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Infections and infestations
Otitis media acute
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Infections and infestations
Pneumonia
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.66%
2/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Injury, poisoning and procedural complications
Extradural hematoma
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.66%
1/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Injury, poisoning and procedural complications
Injury
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.33%
1/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.33%
1/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.66%
1/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign muscle neoplasm
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.66%
1/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Nervous system disorders
Syncope
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Nervous system disorders
Ischemic stroke
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.66%
1/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Renal and urinary disorders
Acute kidney injury
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.33%
1/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.66%
1/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Respiratory, thoracic and mediastinal disorders
Rheumatoid lung
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.33%
1/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Surgical and medical procedures
Polypectomy
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Vascular disorders
Hypertension
|
0.00%
0/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.31%
1/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
Other adverse events
| Measure |
Treatment 1: CT-P17
n=324 participants at risk
Patients were administered CT-P17 (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.
|
Treatment 1: EU-approved Humira
n=324 participants at risk
Patients were administered EU-approved Humira (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.
|
Treatment 2: CT-P17 Maintenance
n=303 participants at risk
All patients who were initially randomly assigned to CT-P17 (40mg/0.4mL) at Day 1 (Week 0) continued their treatment with CT-P17 from Week 26 up to Week 48.
|
Treatment 2: Humira Maintenance
n=152 participants at risk
Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.
|
Treatment 2: Switched to CT-P17
n=152 participants at risk
Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
3.1%
10/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
2.8%
9/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
2.6%
8/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
4.6%
7/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.0%
13/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
5.2%
17/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
5.0%
15/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
3.9%
6/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
5.3%
8/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Gastrointestinal disorders
Diarrhea
|
1.5%
5/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.93%
3/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.66%
2/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
2.0%
3/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
3.3%
5/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
General disorders
Injection site reaction
|
4.9%
16/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
7.1%
23/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.33%
1/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
2.6%
4/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.66%
1/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Infections and infestations
Latent tuberculosis
|
3.7%
12/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
4.6%
15/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.66%
1/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.00%
0/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Infections and infestations
Nasopharyngitis
|
5.2%
17/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
6.2%
20/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
2.0%
6/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
3.3%
5/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
2.0%
3/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Infections and infestations
Pharyngitis
|
3.7%
12/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
3.1%
10/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
1.3%
4/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
2.6%
4/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
2.0%
3/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
18/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
6.8%
22/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
3.3%
10/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
7.2%
11/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
3.9%
6/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Infections and infestations
Urinary tract infection
|
4.6%
15/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
4.6%
15/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
3.0%
9/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
3.3%
5/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
2.0%
3/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Investigations
Alanine aminotransferase increased
|
3.4%
11/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
5.2%
17/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
2.6%
8/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.66%
1/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
4.6%
7/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
|
Investigations
Aspartate aminotransferase increased
|
1.2%
4/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
3.7%
12/324 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
1.3%
4/303 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
0.66%
1/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
2.6%
4/152 • Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place