Trial Outcomes & Findings for PK Similarity Prospective Phase 3 Study in Patients With Rheumatoid Arthritis (NCT NCT02149121)
NCT ID: NCT02149121
Last Updated: 2021-12-16
Results Overview
For evaluation of pharmacokinetics (PK), the primary endpoint was defined as the analysis of serum AUC0-last, AUC0-inf and Cmax of rituximab during the 1st course of the Main Study Period (over the first 24 weeks). During the 1st course of the Main Study Period, blood samples for PK analysis were collected every week from Week 0 to Week 4, every 4 weeks from Week 4 to Week 16, followed by Week 24. AUC0-last: Area under the concentration-time curve from time to the last measurable concentration over both doses of the 1st course
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
384 participants
Primary outcome timeframe
over the first 24 weeks
Results posted on
2021-12-16
Participant Flow
Participants recruited from 76 study centers (including 1 GCP noncompliant study center) in Europe, Asia Pacific, and Latin America.
A total of 495 participants were screened for the study. Of theses, 111 participants were excluded from the study due to screening failure and 384 participants were enrolled in the study. Of these 384 participants, 12 participants from the significantly GCP noncompliant study center were excluded from all analysis populations.
Participant milestones
| Measure |
CT-P10 (Main Study Period)
This group received 1000mg rituximab (CT-P10; experimental drug) by intravenous (IV) infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, Methotrexate (MTX) (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Rituxan (Main Study Period)
This group received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
MabThera (Main Study Period)
This group received 1000mg rituximab (MabThera; EU-approved reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
CT-P10/CT-P10 (Extension Study Period)
For the Extension Study Period, participants, who were assigned to receive CT-P10 with their first infusion in the Main Study Period, were considered as CT-P10/CT-P10 group and maintained CT-P10 for the treatment course of the Extension Study Period at Extension Week 0. This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course in the Extension Study Period followed by 1000mg rituximab (CT-P10; experimental drug) infusions in the Main Study Period. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Rituxan/Rituxan (Extension Study Period)
For the Extension Study Period, participants, who were assigned to receive Rituxan with their first infusion in the Main Study Period, were randomized in a 1:1 ratio to Rituxan/Rituxan group and Rituxan/CT-P10 group at Extension Week 0. This group is for participants who were assigned as Rituxan/Rituxan group and received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course in the Extension Study Period followed by 1000mg rituximab (Rituxan; US-licensed reference product) infusions in the Main Study Period. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Rituxan/CT-P10 (Extension Study Period)
For the Extension Study Period, participants, who were assigned to receive Rituxan with their first infusion in the Main Study Period, were randomized in a 1:1 ratio to Rituxan/Rituxan group and Rituxan/CT-P10 group at Extension Week 0. This group is for participants who were assigned as Rituxan/CT-P10 group and received 1000mg rituximab (CT-P10; experimental drug) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course in the Extension Study Period followed by 1000mg rituximab (Rituxan; US-licensed reference product) infusions in the Main Study Period. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
MabThera/CT-P10 (Extension Study Period)
For the Extension Study Period, participants, who were assigned to receive MabThera with their first infusion in the Main Study Period, were considered as MabThera/CT-P10 group and received CT-P10 for the treatment course of the Extension Study Period at Extension Week 0. This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course in the Extension Study Period followed by 1000mg rituximab (Rituxan; US-licensed reference product) infusions in the Main Study Period. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
|---|---|---|---|---|---|---|---|
|
Main Study Period
STARTED
|
161
|
151
|
60
|
0
|
0
|
0
|
0
|
|
Main Study Period
COMPLETED
|
140
|
134
|
56
|
0
|
0
|
0
|
0
|
|
Main Study Period
NOT COMPLETED
|
21
|
17
|
4
|
0
|
0
|
0
|
0
|
|
Extension Study Period
STARTED
|
0
|
0
|
0
|
122
|
64
|
62
|
47
|
|
Extension Study Period
COMPLETED
|
0
|
0
|
0
|
121
|
64
|
60
|
47
|
|
Extension Study Period
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
CT-P10 (Main Study Period)
This group received 1000mg rituximab (CT-P10; experimental drug) by intravenous (IV) infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, Methotrexate (MTX) (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Rituxan (Main Study Period)
This group received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
MabThera (Main Study Period)
This group received 1000mg rituximab (MabThera; EU-approved reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
CT-P10/CT-P10 (Extension Study Period)
For the Extension Study Period, participants, who were assigned to receive CT-P10 with their first infusion in the Main Study Period, were considered as CT-P10/CT-P10 group and maintained CT-P10 for the treatment course of the Extension Study Period at Extension Week 0. This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course in the Extension Study Period followed by 1000mg rituximab (CT-P10; experimental drug) infusions in the Main Study Period. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Rituxan/Rituxan (Extension Study Period)
For the Extension Study Period, participants, who were assigned to receive Rituxan with their first infusion in the Main Study Period, were randomized in a 1:1 ratio to Rituxan/Rituxan group and Rituxan/CT-P10 group at Extension Week 0. This group is for participants who were assigned as Rituxan/Rituxan group and received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course in the Extension Study Period followed by 1000mg rituximab (Rituxan; US-licensed reference product) infusions in the Main Study Period. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Rituxan/CT-P10 (Extension Study Period)
For the Extension Study Period, participants, who were assigned to receive Rituxan with their first infusion in the Main Study Period, were randomized in a 1:1 ratio to Rituxan/Rituxan group and Rituxan/CT-P10 group at Extension Week 0. This group is for participants who were assigned as Rituxan/CT-P10 group and received 1000mg rituximab (CT-P10; experimental drug) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course in the Extension Study Period followed by 1000mg rituximab (Rituxan; US-licensed reference product) infusions in the Main Study Period. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
MabThera/CT-P10 (Extension Study Period)
For the Extension Study Period, participants, who were assigned to receive MabThera with their first infusion in the Main Study Period, were considered as MabThera/CT-P10 group and received CT-P10 for the treatment course of the Extension Study Period at Extension Week 0. This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course in the Extension Study Period followed by 1000mg rituximab (Rituxan; US-licensed reference product) infusions in the Main Study Period. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
|---|---|---|---|---|---|---|---|
|
Main Study Period
Lack of Efficacy
|
2
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Main Study Period
Withdrawal by Subject
|
9
|
5
|
1
|
0
|
0
|
0
|
0
|
|
Main Study Period
Adverse Event
|
2
|
5
|
1
|
0
|
0
|
0
|
0
|
|
Main Study Period
Protocol Violation
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Study Period
Lost to Follow-up
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Main Study Period
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Study Period
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Study Period
Developed any malignancy
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Main Study Period
Unmet predefined eligibility criteria
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Main Study Period
Disease progression
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Extension Study Period
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
2
|
0
|
Baseline Characteristics
Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall.
Baseline characteristics by cohort
| Measure |
CT-P10 (Main Study Period)
n=161 Participants
This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Rituxan (Main Study Period)
n=151 Participants
This group received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
MabThera (Main Study Period)
n=60 Participants
This group received 1000mg rituximab (MabThera; EU-approved reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
CT-P10/CT-P10 (Extension Study Period)
n=122 Participants
For the Extension Study Period, participants, who were assigned to receive CT-P10 with their first infusion in the Main Study Period, were considered as CT-P10/CT-P10 group and maintained CT-P10 for the treatment course of the Extension Study Period at Extension Week 0. This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course in the Extension Study Period followed by 1000mg rituximab (CT-P10; experimental drug) infusions in the Main Study Period. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Rituxan/Rituxan (Extension Study Period)
n=64 Participants
For the Extension Study Period, participants, who were assigned to receive Rituxan with their first infusion in the Main Study Period, were randomized in a 1:1 ratio to Rituxan/Rituxan group and Rituxan/CT-P10 group at Extension Week 0. This group is for participants who were assigned as Rituxan/Rituxan group and received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course in the Extension Study Period followed by 1000mg rituximab (Rituxan; US-licensed reference product) infusions in the Main Study Period. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Rituxan/CT-P10 (Extension Study Period)
n=62 Participants
For the Extension Study Period, participants, who were assigned to receive Rituxan with their first infusion in the Main Study Period, were randomized in a 1:1 ratio to Rituxan/Rituxan group and Rituxan/CT-P10 group at Extension Week 0. This group is for participants who were assigned as Rituxan/CT-P10 group and received 1000mg rituximab (CT-P10; experimental drug) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course in the Extension Study Period followed by 1000mg rituximab (Rituxan; US-licensed reference product) infusions in the Main Study Period. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
MabThera/CT-P10 (Extension Study Period)
n=47 Participants
For the Extension Study Period, participants, who were assigned to receive MabThera with their first infusion in the Main Study Period, were considered as MabThera/CT-P10 group and received CT-P10 for the treatment course of the Extension Study Period at Extension Week 0. This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course in the Extension Study Period followed by 1000mg rituximab (Rituxan; US-licensed reference product) infusions in the Main Study Period. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Total
n=667 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
0 Participants
Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
0 Participants
Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
1 Participants
n=122 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
0 Participants
n=64 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
0 Participants
n=62 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
0 Participants
n=47 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
1 Participants
n=295 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
0 Participants
Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
0 Participants
Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
105 Participants
n=122 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
57 Participants
n=64 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
52 Participants
n=62 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
44 Participants
n=47 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
258 Participants
n=295 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
|
Age, Categorical
>=65 years
|
0 Participants
Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
0 Participants
Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
0 Participants
Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
16 Participants
n=122 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
7 Participants
n=64 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
10 Participants
n=62 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
3 Participants
n=47 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
36 Participants
n=295 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
|
Age, Continuous
|
53.0 years
n=161 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
53.0 years
n=151 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
51.5 years
n=60 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
52.5 years
n=122 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
52.5 years
n=64 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
53.0 years
n=62 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
50.0 years
n=47 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
52.0 years
n=295 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
|
Sex: Female, Male
Female
|
138 Participants
n=161 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
130 Participants
n=151 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
50 Participants
n=60 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
100 Participants
n=122 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
54 Participants
n=64 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
55 Participants
n=62 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
40 Participants
n=47 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
249 Participants
n=295 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
|
Sex: Female, Male
Male
|
23 Participants
n=161 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
21 Participants
n=151 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
10 Participants
n=60 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
22 Participants
n=122 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
10 Participants
n=64 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
7 Participants
n=62 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
7 Participants
n=47 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
46 Participants
n=295 Participants • Study is divided in 2 period (Main Study Period and Extension Study Period) and baseline measures were separately entered. Therefore, a row population differs from the Overall
|
PRIMARY outcome
Timeframe: over the first 24 weeksPopulation: PK population - The PK analysis set for the Main Study Period consisted of all patients who received 2 full doses (Week 0 and Week 2) of the study drug and provided at least 1 post-treatment PK concentration result during the 1st course in the Main Study Period.
For evaluation of pharmacokinetics (PK), the primary endpoint was defined as the analysis of serum AUC0-last, AUC0-inf and Cmax of rituximab during the 1st course of the Main Study Period (over the first 24 weeks). During the 1st course of the Main Study Period, blood samples for PK analysis were collected every week from Week 0 to Week 4, every 4 weeks from Week 4 to Week 16, followed by Week 24. AUC0-last: Area under the concentration-time curve from time to the last measurable concentration over both doses of the 1st course
Outcome measures
| Measure |
CT-P10 (Main Study Period)
n=62 Participants
This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Rituxan (Main Study Period)
n=60 Participants
This group received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
MabThera (Main Study Period)
n=59 Participants
This group received 1000mg rituximab (MabThera; EU-approved reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Reference Products (Main Study Period)
Reference products group: The combined Rituxan and MabThera groups. This group received 1000mg rituximab (Rituxan and MabThera) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and
1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
|---|---|---|---|---|
|
Analysis of Serum AUC0-last of Rituximab During the 1st Course of the Main Study Period (Over the First 24 Weeks) (ANCOVA)
|
162414.81 h*μg/mL
Standard Error 1.073
|
167309.07 h*μg/mL
Standard Error 1.073
|
172450.97 h*μg/mL
Standard Error 1.075
|
—
|
PRIMARY outcome
Timeframe: at Week 24 of the Main Study PeriodPopulation: PK population - The PK analysis set for the Main Study Period consisted of all patients who received 2 full doses (Week 0 and Week 2) of the study drug and provided at least 1 post-treatment PK concentration result during the 1st course in the Main Study Period.
For evaluation of PK, the primary endpoint was defined as the analysis of serum AUC0-last, AUC0-inf and Cmax of rituximab during the 1st course of the Main Study Period (over the first 24 weeks). During the 1st course of the Main Study Period, blood samples for PK analysis were collected every week from Week 0 to Week 4, every 4 weeks from Week 4 to Week 16, followed by Week 24. AUC0-inf: Area under the concentration-time curve from time 0 extrapolated to infinity over both doses of the 1st course
Outcome measures
| Measure |
CT-P10 (Main Study Period)
n=59 Participants
This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Rituxan (Main Study Period)
n=60 Participants
This group received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
MabThera (Main Study Period)
n=56 Participants
This group received 1000mg rituximab (MabThera; EU-approved reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Reference Products (Main Study Period)
Reference products group: The combined Rituxan and MabThera groups. This group received 1000mg rituximab (Rituxan and MabThera) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and
1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
|---|---|---|---|---|
|
Analysis of Serum AUC0-inf of Rituximab During the 1st Course of the Main Study Period (Over the First 24 Weeks) (ANCOVA)
|
162377.28 h*μg/mL
Standard Error 1.068
|
169480.80 h*μg/mL
Standard Error 1.069
|
180637.81 h*μg/mL
Standard Error 1.072
|
—
|
PRIMARY outcome
Timeframe: at Week 24 of the Main Study PeriodPopulation: PK population - The PK analysis set for the Main Study Period consisted of all patients who received 2 full doses (Week 0 and Week 2) of the study drug and provided at least 1 post-treatment PK concentration result during the 1st course in the Main Study Period.
For evaluation of pharmacokinetics (PK), the primary endpoint was defined as the analysis of serum AUC0-last, AUC0-inf and Cmax of rituximab during the 1st course of the Main Study Period (over the first 24 weeks). During the 1st course of the Main Study Period, blood samples for PK analysis were collected every week from Week 0 to Week 4, every 4 weeks from Week 4 to Week 16, followed by Week 24. Cmax: Observed maximum concentration after the seocnd infusion of the 1st course
Outcome measures
| Measure |
CT-P10 (Main Study Period)
n=62 Participants
This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Rituxan (Main Study Period)
n=59 Participants
This group received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
MabThera (Main Study Period)
n=59 Participants
This group received 1000mg rituximab (MabThera; EU-approved reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Reference Products (Main Study Period)
Reference products group: The combined Rituxan and MabThera groups. This group received 1000mg rituximab (Rituxan and MabThera) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and
1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
|---|---|---|---|---|
|
Analysis of Serum Cmax of Rituximab During the 1st Course of the Main Study Period (Over the First 24 Weeks) (ANCOVA)
|
367.03 ug/mL
Standard Error 1.042
|
386.65 ug/mL
Standard Error 1.042
|
412.40 ug/mL
Standard Error 1.043
|
—
|
PRIMARY outcome
Timeframe: at Week 24 of the Main Study PeriodPopulation: Efficacy population - The efficacy analysis set for the Main Study Period consisted of all who received at least 1 full dose (1000mg) of study drug (CT-P10, Rituxan or MabThera), who had at least 1 post-treatment efficacy result and who did not have any major protocol violation including a violation of the inclusion and exclusion criteria.
For evaluation of efficacy, the primary endpoint was defined as the analysis of change from baseline in disease activity measured by disease activity score 28 (DAS 28) C-reactive protein (CRP) at Week 24 between 2 treatment groups, CT-P10 and reference products (combined Rituxan and MabThera) groups. During the 1st course of the Main Study Period, DAS28 was assessed every 4 weeks from Week 0 to Week 24. DAS28 (CRP) was calculated using the following formula: DAS28 (CRP) = 0.56 X SQRT(TJC28) + 0.28 X SQRT(SJC28) + 0.36 X ln(CRP+1) + 0.014 X GH on VAS + 0.96. DAS28 (CRP) provides a number on a scale from 0 to 10 with higher values indicating greater RA disease activity.
Outcome measures
| Measure |
CT-P10 (Main Study Period)
n=138 Participants
This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Rituxan (Main Study Period)
n=196 Participants
This group received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
MabThera (Main Study Period)
This group received 1000mg rituximab (MabThera; EU-approved reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Reference Products (Main Study Period)
Reference products group: The combined Rituxan and MabThera groups. This group received 1000mg rituximab (Rituxan and MabThera) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and
1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
|---|---|---|---|---|
|
Analysis of Change From Baseline of DAS28 (CRP) at Week 24 (ANCOVA)
|
-2.11 score on a scale
Standard Error 0.176
|
-2.10 score on a scale
Standard Error 0.178
|
—
|
—
|
SECONDARY outcome
Timeframe: at Week 24 of the Main Study PeriodPopulation: Weeks 0 and 24 data were analysed by efficacy population who received at least 1 full dose of study drug and provided at least 1 post treatment efficacy result during 1st course. Week 48 data were analysed by 'efficacy-2nd course subset' who received at least 1 full dose and provided at least 1 post treatment efficacy result during 2nd course.
For evaluation of efficacy, the secondary endpoint was defined as descriptive statistics of mean change from baseline in disease activity measured by DAS 28 (CRP) and DAS28 erythrocyte sedimentation rate (ESR) at Week 24 (efficacy population) and Week 48 (efficacy population - 2nd treatment course in Main Study Period subset) for the Main Study Period between 2 treatment groups, CT-P10 and reference products (combined Rituxan and MabThera) groups. DAS28 was assessed every 4 weeks from Week 0 to Week 24 during the 1st treatment course of the Main Study Period and every 8 weeks from Week 24 to Week 48 during the 2nd treatment course of the Main Study Period. DAS28 (CRP) was calculated using the following formula: DAS28 (CRP) = 0.56 X SQRT(TJC28) + 0.28 X SQRT(SJC28) + 0.36 X ln(CRP+1) + 0.014 X GH on VAS + 0.96. DAS28 (CRP) provides a number on a scale from 0 to 10 with higher values indicating greater RA disease activity.
Outcome measures
| Measure |
CT-P10 (Main Study Period)
n=155 Participants
This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Rituxan (Main Study Period)
n=144 Participants
This group received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
MabThera (Main Study Period)
n=59 Participants
This group received 1000mg rituximab (MabThera; EU-approved reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Reference Products (Main Study Period)
n=203 Participants
Reference products group: The combined Rituxan and MabThera groups. This group received 1000mg rituximab (Rituxan and MabThera) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and
1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
|---|---|---|---|---|
|
Descriptive Statistics for Means (SD) for Baseline Value and Change From Baseline in Disease Activity Measured by DAS28 (CRP) of the Main Study Period
Week 0 (Baseline)
|
5.8 score on a scale
Standard Deviation 0.91
|
5.8 score on a scale
Standard Deviation 0.92
|
6.0 score on a scale
Standard Deviation 0.87
|
5.8 score on a scale
Standard Deviation 0.91
|
|
Descriptive Statistics for Means (SD) for Baseline Value and Change From Baseline in Disease Activity Measured by DAS28 (CRP) of the Main Study Period
Week 24 (1st course Week 24)
|
-2.3 score on a scale
Standard Deviation 1.06
|
-2.3 score on a scale
Standard Deviation 1.11
|
-2.3 score on a scale
Standard Deviation 1.30
|
-2.3 score on a scale
Standard Deviation 1.17
|
|
Descriptive Statistics for Means (SD) for Baseline Value and Change From Baseline in Disease Activity Measured by DAS28 (CRP) of the Main Study Period
Week 48 (2nd course Week 24)
|
-2.7 score on a scale
Standard Deviation 1.17
|
-2.6 score on a scale
Standard Deviation 1.32
|
-2.7 score on a scale
Standard Deviation 1.32
|
-2.6 score on a scale
Standard Deviation 1.32
|
SECONDARY outcome
Timeframe: at Week 24 of the Main Study PeriodPopulation: Efficacy - Extension Study Period subset: The "efficacy - Extension Study Period subset" consisted of all patients in the efficacy population who received at least 1 full dose (1000 mg) of study drug and provided at least 1 post-treatment efficacy result during the Extension Study Period.
For evaluation of efficacy, the secondary endpoint was defined as descriptive statistics of mean change from baseline in disease activity measured by DAS28 (CRP) and DAS28 (ESR) at Week 72 (efficacy population-Extension Study Period subset) for the Extension Study Period between 4 treatment groups, CT-P10/CT-P10, Rituxan/Rituxan, Rituxan/CT-P10 and MabThera/CT-P10 groups. DAS28 was assessed every 8 weeks from Week 48 (Week 0 of the Extension Study Period) to Week 72 (Week 24 of the Extension Study Period) during the Extension Study Period. DAS28 (CRP) was calculated using the following formula: DAS28 (CRP) = 0.56 X SQRT(TJC28) + 0.28 X SQRT(SJC28) + 0.36 X ln(CRP+1) + 0.014 X GH on VAS + 0.96. DAS28 (CRP) provides a number on a scale from 0 to 10 with higher values indicating greater RA disease activity.
Outcome measures
| Measure |
CT-P10 (Main Study Period)
n=120 Participants
This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Rituxan (Main Study Period)
n=64 Participants
This group received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
MabThera (Main Study Period)
n=60 Participants
This group received 1000mg rituximab (MabThera; EU-approved reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Reference Products (Main Study Period)
n=47 Participants
Reference products group: The combined Rituxan and MabThera groups. This group received 1000mg rituximab (Rituxan and MabThera) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and
1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
|---|---|---|---|---|
|
Descriptive Statistics for Means (SD) for Baseline Value and Change From Baseline in Disease Activity Measured by DAS28 (CRP) of the Extension Study Period
|
-3.0 score on a scale
Standard Deviation 1.20
|
-3.0 score on a scale
Standard Deviation 1.32
|
-2.9 score on a scale
Standard Deviation 1.27
|
-3.0 score on a scale
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: at Week 24 of the Main Study PeriodPopulation: Weeks 0 and 24 data were analysed by efficacy population who received at least 1 full dose of study drug and provided at least 1 post treatment efficacy result during 1st course. Week 48 data were analysed by 'efficacy-2nd course subset' who received at least 1 full dose and provided at least 1 post treatment efficacy result during 2nd course.
For evaluation of efficacy, the secondary endpoint was defined as descriptive statistics of mean change from baseline in disease activity measured by DAS 28 (CRP) and DAS28 (ESR) at Week 24 (efficacy population) and Week 48 (efficacy population - 2nd treatment course in Main Study Period subset) for the Main Study Period between 2 treatment groups, CT-P10 and reference products (combined Rituxan and MabThera) groups. DAS28 was assessed every 4 weeks from Week 0 to Week 24 during the 1st treatment course of the Main Study Period and every 8 weeks from Week 24 to Week 48 during the 2nd treatment course of the Main Study Period. DAS28 (ESR) was calculated using the following formula: DAS28 (CRP) = 0.56 X SQRT(TJC28) + 0.28 X SQRT(SJC28) + 0.36 X ln(ESR) + 0.014 X GH on VAS. DAS28 (ESR) provides a number on a scale from 0 to 10 with higher values indicating greater RA disease activity.
Outcome measures
| Measure |
CT-P10 (Main Study Period)
n=155 Participants
This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Rituxan (Main Study Period)
n=144 Participants
This group received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
MabThera (Main Study Period)
n=59 Participants
This group received 1000mg rituximab (MabThera; EU-approved reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Reference Products (Main Study Period)
n=203 Participants
Reference products group: The combined Rituxan and MabThera groups. This group received 1000mg rituximab (Rituxan and MabThera) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and
1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
|---|---|---|---|---|
|
Descriptive Statistics for Actual Value and Change From Baseline in Disease Activity Measured by DAS28 (ESR) of the Main Study Period
Week 0 (Baseline)
|
6.7 score on a scale
Standard Deviation 0.83
|
6.7 score on a scale
Standard Deviation 0.84
|
6.8 score on a scale
Standard Deviation 0.75
|
6.7 score on a scale
Standard Deviation 0.81
|
|
Descriptive Statistics for Actual Value and Change From Baseline in Disease Activity Measured by DAS28 (ESR) of the Main Study Period
Week 24 (1st course Week 24)
|
-2.5 score on a scale
Standard Deviation 1.13
|
-2.5 score on a scale
Standard Deviation 1.13
|
-2.3 score on a scale
Standard Deviation 1.31
|
-2.5 score on a scale
Standard Deviation 1.18
|
|
Descriptive Statistics for Actual Value and Change From Baseline in Disease Activity Measured by DAS28 (ESR) of the Main Study Period
Week 48 (2nd course Week 24)
|
-2.9 score on a scale
Standard Deviation 1.29
|
-2.8 score on a scale
Standard Deviation 1.42
|
-2.9 score on a scale
Standard Deviation 1.32
|
-2.8 score on a scale
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: at Week 24 of the Main Study PeriodPopulation: Efficacy - Extension Study Period subset: The "efficacy - Extension Study Period subset" consisted of all patients in the efficacy population who received at least 1 full dose (1000 mg) of study drug and provided at least 1 post-treatment efficacy result during the Extension Study Period.
For evaluation of efficacy, the secondary endpoint was defined as descriptive statistics of mean change from baseline in disease activity measured by DAS28 (CRP) and DAS28 (ESR) at Week 72 (efficacy population-Extension Study Period subset) for the Extension Study Period between 4 treatment groups, CT-P10/CT-P10, Rituxan/Rituxan, Rituxan/CT-P10 and MabThera/CT-P10 groups. DAS28 was assessed every 8 weeks from Week 48 (Week 0 of the Extension Study Period) to Week 72 (Week 24 of the Extension Study Period) during the Extension Study Period. DAS28 (ESR) was calculated using the following formula: DAS28 (CRP) = 0.56 X SQRT(TJC28) + 0.28 X SQRT(SJC28) + 0.36 X ln(ESR) + 0.014 X GH on VAS. DAS28 (ESR) provides a number on a scale from 0 to 10 with higher values indicating greater RA disease activity.
Outcome measures
| Measure |
CT-P10 (Main Study Period)
n=120 Participants
This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Rituxan (Main Study Period)
n=64 Participants
This group received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
MabThera (Main Study Period)
n=60 Participants
This group received 1000mg rituximab (MabThera; EU-approved reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Reference Products (Main Study Period)
n=47 Participants
Reference products group: The combined Rituxan and MabThera groups. This group received 1000mg rituximab (Rituxan and MabThera) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and
1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
|---|---|---|---|---|
|
Descriptive Statistics for Actual Value and Change From Baseline in Disease Activity Measured by DAS28 (ESR) of the Extension Study Period
|
-3.3 score on a scale
Standard Deviation 1.24
|
-3.3 score on a scale
Standard Deviation 1.41
|
-3.2 score on a scale
Standard Deviation 1.36
|
-3.2 score on a scale
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: Week 24Population: PD population - The PD analysis set for the Main Study Period consisted of all patients who received at least 1 full dose (1000mg) of study drug and provided at least 1 post-treatment PD result during the 1st course in the Main Study Period.
For evaluation of pharmacodynamics (PD), the endpoint was defined as B-cell counts at Week 24 between 2 treatment groups, CT-P10 and reference products (combined Rituxan and MabThera) groups. During the 1st course of the Main Study Period, B-cell kinetics blood samples were collected every week from Week 0 to Week 4, every 4 weeks from Week 4 to Week 16, followed by Week 24.
Outcome measures
| Measure |
CT-P10 (Main Study Period)
n=123 Participants
This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Rituxan (Main Study Period)
n=173 Participants
This group received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
MabThera (Main Study Period)
This group received 1000mg rituximab (MabThera; EU-approved reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Reference Products (Main Study Period)
Reference products group: The combined Rituxan and MabThera groups. This group received 1000mg rituximab (Rituxan and MabThera) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and
1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
|---|---|---|---|---|
|
Analysis of B-cell Counts at Week 24 of the Main Study Period (ANCOVA)
|
25.29 cells/mcL
Standard Error 1.074
|
24.70 cells/mcL
Standard Error 1.073
|
—
|
—
|
Adverse Events
CT-P10 (Main Study Period)
Serious events: 13 serious events
Other events: 88 other events
Deaths: 1 deaths
Rituxan (Main Study Period)
Serious events: 14 serious events
Other events: 72 other events
Deaths: 0 deaths
MabThera (Main Study Period)
Serious events: 4 serious events
Other events: 29 other events
Deaths: 0 deaths
CT-P10/CT-P10 (Extension Study Period)
Serious events: 4 serious events
Other events: 27 other events
Deaths: 0 deaths
Rituxan/Rituxan (Extension Study Period)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Rituxan/CT-P10 (Extension Study Period)
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
MabThera/CT-P10 (Extension Study Period)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CT-P10 (Main Study Period)
n=161 participants at risk
This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Rituxan (Main Study Period)
n=151 participants at risk
This group received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
MabThera (Main Study Period)
n=60 participants at risk
This group received 1000mg rituximab (MabThera; EU-approved reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
CT-P10/CT-P10 (Extension Study Period)
n=122 participants at risk
For the Extension Study Period, participants, who were assigned to receive CT-P10 with their first infusion in the Main Study Period, were considered as CT-P10/CT-P10 group and maintained CT-P10 for the treatment course of the Extension Study Period at Extension Week 0. This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Rituxan/Rituxan (Extension Study Period)
n=64 participants at risk
For the Extension Study Period, participants, who were assigned to receive Rituxan with their first infusion in the Main Study Period, were randomized in a 1:1 ratio to Rituxan/Rituxan group and Rituxan/CT-P10 group at Extension Week 0. This group received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Rituxan/CT-P10 (Extension Study Period)
n=62 participants at risk
For the Extension Study Period, participants, who were assigned to receive Rituxan with their first infusion in the Main Study Period, were randomized in a 1:1 ratio to Rituxan/Rituxan group and Rituxan/CT-P10 group at Extension Week 0. This group received 1000mg rituximab (CT-P10) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
MabThera/CT-P10 (Extension Study Period)
n=47 participants at risk
For the Extension Study Period, participants, who were assigned to receive MabThera with their first infusion in the Main Study Period, were considered as MabThera/CT-P10 group and received CT-P10 for the treatment course of the Extension Study Period at Extension Week 0. This group received 1000mg rituximab (CT-P10) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/161 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/151 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
1.7%
1/60 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.62%
1/161 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.66%
1/151 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/60 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/161 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.66%
1/151 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/60 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/161 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.66%
1/151 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/60 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
General disorders
Chest pain
|
0.62%
1/161 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/151 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/60 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.62%
1/161 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/151 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/60 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.62%
1/161 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/151 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/60 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Infections and infestations
Cellulitis
|
0.62%
1/161 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.66%
1/151 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/60 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Infections and infestations
Localised infection
|
0.00%
0/161 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.66%
1/151 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/60 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/161 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.66%
1/151 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/60 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Infections and infestations
Pneumonia
|
0.62%
1/161 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.66%
1/151 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/60 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Injury, poisoning and procedural complications
Fracture
|
2.5%
4/161 • Number of events 4 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
1.3%
2/151 • Number of events 2 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/60 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/161 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
1.3%
2/151 • Number of events 2 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/60 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/161 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.66%
1/151 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/60 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/161 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.66%
1/151 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/60 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Musculoskeletal and connective tissue disorders
Hand deformity
|
0.62%
1/161 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/151 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/60 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/161 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/151 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
1.7%
1/60 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/161 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.66%
1/151 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/60 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/161 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.66%
1/151 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
1.7%
1/60 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangioma
|
0.00%
0/161 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/151 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
1.7%
1/60 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Nervous system disorders
Tremor
|
0.62%
1/161 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/151 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/60 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/161 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.66%
1/151 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/60 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.62%
1/161 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/151 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/60 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.62%
1/161 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/151 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/60 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/161 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/151 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/60 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.82%
1/122 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/161 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/151 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/60 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.82%
1/122 • Number of events 2 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/161 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/151 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/60 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
2.5%
3/122 • Number of events 3 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
Other adverse events
| Measure |
CT-P10 (Main Study Period)
n=161 participants at risk
This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Rituxan (Main Study Period)
n=151 participants at risk
This group received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
MabThera (Main Study Period)
n=60 participants at risk
This group received 1000mg rituximab (MabThera; EU-approved reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
CT-P10/CT-P10 (Extension Study Period)
n=122 participants at risk
For the Extension Study Period, participants, who were assigned to receive CT-P10 with their first infusion in the Main Study Period, were considered as CT-P10/CT-P10 group and maintained CT-P10 for the treatment course of the Extension Study Period at Extension Week 0. This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Rituxan/Rituxan (Extension Study Period)
n=64 participants at risk
For the Extension Study Period, participants, who were assigned to receive Rituxan with their first infusion in the Main Study Period, were randomized in a 1:1 ratio to Rituxan/Rituxan group and Rituxan/CT-P10 group at Extension Week 0. This group received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
Rituxan/CT-P10 (Extension Study Period)
n=62 participants at risk
For the Extension Study Period, participants, who were assigned to receive Rituxan with their first infusion in the Main Study Period, were randomized in a 1:1 ratio to Rituxan/Rituxan group and Rituxan/CT-P10 group at Extension Week 0. This group received 1000mg rituximab (CT-P10) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
MabThera/CT-P10 (Extension Study Period)
n=47 participants at risk
For the Extension Study Period, participants, who were assigned to receive MabThera with their first infusion in the Main Study Period, were considered as MabThera/CT-P10 group and received CT-P10 for the treatment course of the Extension Study Period at Extension Week 0. This group received 1000mg rituximab (CT-P10) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
14.9%
24/161 • Number of events 32 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
19.9%
30/151 • Number of events 31 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
15.0%
9/60 • Number of events 12 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
8.2%
10/122 • Number of events 10 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
15.6%
10/64 • Number of events 10 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
12.9%
8/62 • Number of events 10 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Infections and infestations
Urinary tract infection
|
9.3%
15/161 • Number of events 23 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
5.3%
8/151 • Number of events 14 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
3.3%
2/60 • Number of events 2 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
6.6%
8/122 • Number of events 10 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
3.1%
2/64 • Number of events 2 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
3.2%
2/62 • Number of events 3 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
2.1%
1/47 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Infections and infestations
Lower respiratory tract infection
|
6.2%
10/161 • Number of events 11 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
4.6%
7/151 • Number of events 9 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
5.0%
3/60 • Number of events 3 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.82%
1/122 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
4.7%
3/64 • Number of events 3 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
3.2%
2/62 • Number of events 2 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
4.3%
2/47 • Number of events 3 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Infections and infestations
Rhinitis
|
1.9%
3/161 • Number of events 4 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
4.0%
6/151 • Number of events 6 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
1.7%
1/60 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
1.6%
1/64 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Infections and infestations
Infleunza
|
1.2%
2/161 • Number of events 2 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/151 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
3.3%
2/60 • Number of events 2 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Injury, poisoning and procedural complications
Infusion-related reaction
|
20.5%
33/161 • Number of events 39 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
7.9%
12/151 • Number of events 15 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
21.7%
13/60 • Number of events 15 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
3.3%
4/122 • Number of events 5 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
4.7%
3/64 • Number of events 3 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
3.2%
2/62 • Number of events 2 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
4.3%
2/47 • Number of events 3 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
4/161 • Number of events 4 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
3.3%
5/151 • Number of events 6 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
1.7%
1/60 • Number of events 3 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
5/161 • Number of events 5 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
2.6%
4/151 • Number of events 5 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
1.7%
1/60 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
1.6%
2/122 • Number of events 2 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Investigations
Alanine aminotransferase increased
|
3.1%
5/161 • Number of events 5 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
4.6%
7/151 • Number of events 10 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/60 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.82%
1/122 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
1.6%
1/62 • Number of events 2 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Nervous system disorders
Headache
|
5.0%
8/161 • Number of events 9 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
5.3%
8/151 • Number of events 9 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
3.3%
2/60 • Number of events 3 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.82%
1/122 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
2.1%
1/47 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
4.3%
7/161 • Number of events 7 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
2.6%
4/151 • Number of events 5 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
1.7%
1/60 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.82%
1/122 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
1.6%
1/64 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.7%
6/161 • Number of events 7 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
3.3%
5/151 • Number of events 5 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
3.3%
2/60 • Number of events 2 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.82%
1/122 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
4.8%
3/62 • Number of events 3 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
2.1%
1/47 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.9%
3/161 • Number of events 3 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.66%
1/151 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
5.0%
3/60 • Number of events 3 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Vascular disorders
Hypertension
|
3.7%
6/161 • Number of events 6 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
2.6%
4/151 • Number of events 5 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/60 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.82%
1/122 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Psychiatric disorders
Depression
|
0.62%
1/161 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.66%
1/151 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
3.3%
2/60 • Number of events 2 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Infections and infestations
Gastroenteritis
|
1.9%
3/161 • Number of events 3 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
1.3%
2/151 • Number of events 2 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/60 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/64 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
3.2%
2/62 • Number of events 2 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
|
Infections and infestations
Vaginal infection
|
0.62%
1/161 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.66%
1/151 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
1.7%
1/60 • Number of events 1 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/122 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
3.1%
2/64 • Number of events 2 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/62 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
0.00%
0/47 • Serious adverse events (SAEs) and adverse events (AEs) were assessed from the date the informed consent form was signed until the participant's last visit, up to week 24 of extension period (up to week 72).
At each level of summarization, a participant is counted only once if they reported one or more events. Only the most severe event is counted. SAEs and AEs are considered to have occurred in the Main Study Period if start date is before the first infusion of the Extension Study Period or if participant did not enter the Extension Study Period, and considered to have occurred in the Extension Study Period if the start date is on or after the date of first infusion of the Extension Study Period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators could publish any information whatsoever and/or any discussion relating to Sponsor, Confidential Information, Inventions or work performed by investigator for Sponsor with the prior written consent of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER